Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- BRWProtector, Dental1Product Code
- BSFAbsorber, Carbon-Dioxide1Product Code
- BSJMask, Gas, Anesthetic1Product Code
- BSKCuff, Tracheal Tube, Inflatable2Product Code
- BSNFilter, Conduction, Anesthetic2Product Code
- BSOCatheter, Conduction, Anesthetic2Product Code
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2Product Code
- BSRStylet, Tracheal Tube1Product Code
- BSZGas-Machine, Anesthesia2Product Code
- BTBHook, Ether1Product Code
- BTCBag, Reservoir1Product Code
- BTKStrap, Head, Gas Mask1Product Code
- BTLVentilator, Emergency, Powered (Resuscitator)2Product Code
- BTMVentilator, Emergency, Manual (Resuscitator)2Product Code
- BTOTube, Tracheostomy (W/Wo Connector)2Product Code
- BTPDropper, Ether1Product Code
- BTQAirway, Nasopharyngeal1Product Code
- BTRTube, Tracheal (W/Wo Connector)2Product Code
- BTSTube, Bronchial (W/Wo Connector)2Product Code
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2Product Code
- BWBForceps, Tube Introduction1Product Code
- BWCNeedle, Emergency Airway2Product Code
- BWFSpirometer, Therapeutic (Incentive)2Product Code
- BWLApparatus, Electronanesthesia3Product Code
- BYDCondenser, Heat And Moisture (Artificial Nose)1Product Code
- BYEAttachment, Breathing, Positive End Expiratory Pressure2Product Code
- BYFMask, Oxygen, Low Concentration, Venturi1Product Code
- BYGMask, Oxygen1Product Code
- BYHDrain, Tee (Water Trap)1Product Code
- BYIPercussor, Powered-Electric2Product Code
- BYJUnit, Liquid-Oxygen, Portable2Product Code
- BYKTent, Oxygen, Electrically Powered2Product Code
- BYLTent, Oxygen1Product Code
- BYNChair, Posture, For Cardiac And Pulmonary Treatment1Product Code
- BYOBottle, Blow1Product Code
- BYPMouthpiece, Breathing1Product Code
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)2Product Code
- BYWDevice, Rebreathing1Product Code
- BYXTubing, Pressure And Accessories1Product Code
- BZAConnector, Airway (Extension)1Product Code
- BZBCatheter, Nasal, Oxygen1Product Code
- BZDVentilator, Non-Continuous (Respirator)2Product Code
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2Product Code
- BZOSet, Tubing And Support, Ventilator (W Harness)1Product Code
- BZRMixer, Breathing Gases, Anesthesia Inhalation2Product Code
- CADVaporizer, Anesthesia, Non-Heated2Product Code
- CAEAirway, Oropharyngeal, Anesthesiology1Product Code
- CAFNebulizer (Direct Patient Interface)2Product Code
- K251572eRapid with eTrack System2Cleared 510(K)
- K251659Mesh Nebulizer (H6)2Cleared 510(K)
- K244035Portable mesh nebulizer (JM821)2Cleared 510(K)
- K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)2Cleared 510(K)
- K250022HeroTracker Sense2Cleared 510(K)
- K250583AdheResp Smart Breath-actuated Mesh Nebulizer2Cleared 510(K)
- K242354AllNEB2Cleared 510(K)
- K233553MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter2Cleared 510(K)
- K232507Aerogen®Solo Nebulizer System2Cleared 510(K)
- K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%2Cleared 510(K)
- K231058Hudson RCI® AddiPak® Unit Dose Vial2Cleared 510(K)
- K230379Portable (Ultrasonic) Nebulizer2Cleared 510(K)
- K230602Hudson RCI® TurboMist™ Nebulizer System2Cleared 510(K)
- K223367Ochsner Connected Inhaler Sensor2Cleared 510(K)
- K220145Monaghan medical filtered mouthpiece kit2Cleared 510(K)
- K223840eRapid Nebulizer System2Cleared 510(K)
- K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)2Cleared 510(K)
- K220955Hudson RCI Variable concentration Large Volume Nebulizer (1770)2Cleared 510(K)
- K222247Hailie Sensor NF01102Cleared 510(K)
- K220869Vapotherm Aerosol Adapter AAA-22Cleared 510(K)
- K221994Hailie Sensor NF0107 & NF01082Cleared 510(K)
- K220622Hailie Sensor NF01062Cleared 510(K)
- K212395Nebulizer2Cleared 510(K)
- K211560Airvo Nebulizer Adapter2Cleared 510(K)
- K210126Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%2Cleared 510(K)
- K203155BreatheSuite MDI V12Cleared 510(K)
- K211233Hailie Sensor NF01092Cleared 510(K)
- K192971Nebulizer Kit2Cleared 510(K)
- K202171Pulmogine Vibrating Mesh Nebulizer2Cleared 510(K)
- K203400Corrugated tube with mouthpiece accessory2Cleared 510(K)
- K201397Ultrasonic Mesh Nebulizer2Cleared 510(K)
- K201167AireHealth NebulizerTM2Cleared 510(K)
- K182906Portable Mesh Nebulizer2Cleared 510(K)
- K200063AeroEclipse* ONE BAN2Cleared 510(K)
- K192633GUS831 Compressor Nebulizer2Cleared 510(K)
- K192724Propeller Sensor for Symbicort2Cleared 510(K)
- K191270Proneb Max2Cleared 510(K)
- K183586CapMedic2Cleared 510(K)
- K182638Hailie Sensor2Cleared 510(K)
- K182573Hailie Sensor2Cleared 510(K)
- K181405Hailie Sensor2Cleared 510(K)
- K180871Portable Nebulizer2Cleared 510(K)
- K171549Intelligent Mesh Nebulizer2Cleared 510(K)
- K180770Propeller Sensor for Neohaler2Cleared 510(K)
- K180407Smartinhaler2Cleared 510(K)
- K170886HOMED Mesh Nebulizer2Cleared 510(K)
- K173825MC 300R* Nebulizer2Cleared 510(K)
- K173310SmartTouch2Cleared 510(K)
- K173367MC 300* Nebulizer2Cleared 510(K)
- K170916Portable Nebulizer2Cleared 510(K)
- K170853InnoSpire Go2Cleared 510(K)
- K161586The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)2Cleared 510(K)
- K163485SmartTouch2Cleared 510(K)
- K153748AirLife Misty Finity Nebulizer2Cleared 510(K)
- K162041Airworks Nebulizer pe1200m2Cleared 510(K)
- K162785Velox Nebulizer System2Cleared 510(K)
- K162753RTC 26-C Inline Aerosol Adapter2Cleared 510(K)
- K161454Propeller Sensor Model 2015-E2Cleared 510(K)
- K153010Hudson RCI AquaPak Sterile Prefilled Nebulizers2Cleared 510(K)
- K152882Propeller System2Cleared 510(K)
- K152482Propeller Sensor Model 2014-R2Cleared 510(K)
- K142541POCKET NEB2Cleared 510(K)
- K143719Aeroneb USB Contoller System2Cleared 510(K)
- K150591Besmed Reusable Jet Nebulizer2Cleared 510(K)
- K143671Propeller Model 2014-D Sensor2Cleared 510(K)
- K142516Propeller System2Cleared 510(K)
- K142153HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML2Cleared 510(K)
- K142960Propeller System 2014-R2Cleared 510(K)
- K142059FOX MOBILE2Cleared 510(K)
- K140237DISPOSABLE NEBULIZER SET2Cleared 510(K)
- K141214AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS2Cleared 510(K)
- K133360AERONEB SOLO; AERONEB SOLO ADAPTER2Cleared 510(K)
- K141140COMP A-I-R2Cleared 510(K)
- K140919RESPICONNECT ADAPTER2Cleared 510(K)
- K133105BREEZE NEBULIZER (NBR-10X)2Cleared 510(K)
- K140211ULTRASONIC MESH NEBULIZER2Cleared 510(K)
- K140638PROPELLER SYSTEM - MODEL 22Cleared 510(K)
- K133951SMARTTOUCH2Cleared 510(K)
- K132247ULTRASONIC MESH NEBULIZER2Cleared 510(K)
- K123030COMPRESSOR NEBULIZER MODEL MCN-S600XX2Cleared 510(K)
- K130379ROLLINS 7 OXYGEN MASK2Cleared 510(K)
- K123527AIRLIFE2Cleared 510(K)
- K121770HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER2Cleared 510(K)
- K122060CLEVER TD-7001NEBULIZER2Cleared 510(K)
- K121520ULTRASONIC NEBULIZER (MESH TYPE)2Cleared 510(K)
- K130091PULMOSAL2Cleared 510(K)
- K123614SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)2Cleared 510(K)
- K121969U-RIGHT COMPRESSOR NEBULIZER2Cleared 510(K)
- K122857HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-31002Cleared 510(K)
- K121154ULTRASONIC NEBULIZER2Cleared 510(K)
- K111246SPIRALE DRUG DELIVERY SYSTEM2Cleared 510(K)
- K121609ASTHMAPOLIS SYSTEM2Cleared 510(K)
- K112824QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER2Cleared 510(K)
- K113033SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML2Cleared 510(K)
- K112859ERAPID NEBULIZER SYSTEM2Cleared 510(K)
- K120939AERONEB PRO2Cleared 510(K)
- K120051SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML2Cleared 510(K)
- K112041KOO SMALL VOLUME NEBULIZER (SVN)2Cleared 510(K)
- K112564QUIXIE NEBULIZER2Cleared 510(K)
- K102454I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM2Cleared 510(K)
- K111570MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR2Cleared 510(K)
- K110860COMP A-I-R2Cleared 510(K)
- K102719ATLANTEAN TRIGGER NEBULIZER2Cleared 510(K)
- K110273AEROVENT PLUS CHC2Cleared 510(K)
- K103635CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S2Cleared 510(K)
- K101552FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH20012Cleared 510(K)
- K101953SMDIA-10002Cleared 510(K)
- K102658MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS2Cleared 510(K)
- K102240NIVO NEBULIZER SYSTEM2Cleared 510(K)
- K101424PHARMACARIBE INHALED SALINE SOLUTIONS2Cleared 510(K)
- K101857RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V2Cleared 510(K)
- K092859MERITS MODEL N SERIES NEBULIZER COMPRESSORS2Cleared 510(K)
- K100285LITETOUCH MASK2Cleared 510(K)
- K092560PARI SINUS2Cleared 510(K)
- K100380ALTERA NEBULIZER SYSTEM, MODEL 678G10022Cleared 510(K)
- K092918PARI VIOS2Cleared 510(K)
- K091794CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/2022Cleared 510(K)
- K091111RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC2Cleared 510(K)
- K090730AKITA JET2Cleared 510(K)
- K091272BESMED JET NEBULIZER BOTTLE SET2Cleared 510(K)
- K091803SMARTTRACK SYSTEM2Cleared 510(K)
- K083256ULTRASONIC NEBULIZER SYSTEM, MODEL KN-92102Cleared 510(K)
- K090840VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.2Cleared 510(K)
- K090307DDI ULTRASONIC NEBULIZER SYSTEM2Cleared 510(K)
- K090065AEROCHAMBER MINI VENTILATION CHAMBER2Cleared 510(K)
- K082878NEVONI CLASSIC, MODEL 6600-PO2Cleared 510(K)
- K082541HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM2Cleared 510(K)
- K081650AERONEB GO NEBULIZER2Cleared 510(K)
- K081738ULTRASONIC NEBULIZER SYSTEM, MODEL HL1002Cleared 510(K)
- K082009HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS2Cleared 510(K)
- K080926AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER2Cleared 510(K)
- K080969HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-5102Cleared 510(K)
- K072136ULTRASONIC NEBULISER MODEL 20102Cleared 510(K)
- K080657NEB-90 LARGE VOLUME MEDICATION NEBULIZER2Cleared 510(K)
- K080230NEB-U-MASK SYSTEM, MODELS 1895, 18962Cleared 510(K)
- K072163HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 52Cleared 510(K)
- K072494AG-CLASSIC2Cleared 510(K)
- K063716AEROSOL SYSTEM2Cleared 510(K)
- K072670MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER2Cleared 510(K)
- K072822FUNHALER, MODEL V-201E2Cleared 510(K)
- K072019AKITA2 APIXNEB2Cleared 510(K)
- K070411AMSURE NEBULIZER2Cleared 510(K)
- K072418OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER2Cleared 510(K)
- K072119AIRLIFE NEBULIZER CAP2Cleared 510(K)
- K062484FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS2Cleared 510(K)
- K070990APEX MEDICAL MOBINEB, 9R-027 SERIES2Cleared 510(K)
- K070642AERONEB PROFESSIONAL NEBULIZER SYSTEM2Cleared 510(K)
- K070498HYPER SAL2Cleared 510(K)
- K070948HSINER NEBULIZER BOTTLE2Cleared 510(K)
- K062014FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB2Cleared 510(K)
- K063449DELUXE NEBULIZER2Cleared 510(K)
- K062263OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U222Cleared 510(K)
- K062952C300 SERIES AIR NEBULIZER COMPRESSOR2Cleared 510(K)
- K062689SIDESTREAM PLUS2Cleared 510(K)
- K063103AG-EDGE, MODEL 912002Cleared 510(K)
- K062811DPILOG, MODEL DPC-5122Cleared 510(K)
- K062158LC SPRINT STAR2Cleared 510(K)
- K053490MERITS HEALTH PRODUCTS PORTABLE NEBULIZER2Cleared 510(K)
- K060497BABYAIR2Cleared 510(K)
- K060404AG-PLUS, MODEL 912102Cleared 510(K)
- K060842REVJET TURBO2Cleared 510(K)
- K061381LC STAR WITH NASAL ADAPTER2Cleared 510(K)
- K060811OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C302Cleared 510(K)
- K060357TREK S NEBULIZER COMPRESSOR2Cleared 510(K)
- K053360AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C2Cleared 510(K)
- K060399LC SPRINT NEBULIZER2Cleared 510(K)
- K053605AEROECLIPSE II BREATH ACTUATED NEBULIZER2Cleared 510(K)
- K052438EMG HANDLE NEBULIZER NB02 SERIES2Cleared 510(K)
- K052811HSINER JET NEBULIZER, MODEL HS-311002Cleared 510(K)
- K053203MYNEB NEBULIZER, MODEL RDD1002Cleared 510(K)
- K052941I-NEB INSIGHT AAD SYSTEM2Cleared 510(K)
- K042991I-NEB AAD SYSTEM2Cleared 510(K)
- K051260SCHUCO MIST AND SCHUCO DELUXE MIST2Cleared 510(K)
- K050183SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES2Cleared 510(K)
- K051365COMPRESSOR NEBULIZER SYSTEM, MODEL KN-93212Cleared 510(K)
- K043238COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES2Cleared 510(K)
- K051284MD TURBO2Cleared 510(K)
- K050104APEX MEDICAL MININEB & MINIPLUS2Cleared 510(K)
- K042483INVACARE PRO, COMPACT AND PORTABLE DESKTOP2Cleared 510(K)
- K042546FUNHALER, MODEL FH 1012Cleared 510(K)
- K042655INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS4562Cleared 510(K)
- K041079GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-1032Cleared 510(K)
- K041082NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER2Cleared 510(K)
- K031370SHINMED MODE SW-988 UNTRASONIC NEBULIZER2Cleared 510(K)
- K041327MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES2Cleared 510(K)
- K040439MDI TRIGGER GUARD2Cleared 510(K)
- K041418AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER2Cleared 510(K)
- K032170TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 50002Cleared 510(K)
- K030396OMNI~NEB; OMNI~MAX2Cleared 510(K)
- K033833EFLOW ELECTRONIC INHALER/NEBULIZER2Cleared 510(K)
- K030747PRODOSE AAD SYSTEM2Cleared 510(K)
- K040718TRUST2Cleared 510(K)
- K031982BIRDSONG LEVERHALER, MODEL LH-10002Cleared 510(K)
- K032516HIOX80 AEROSOL ADAPTER2Cleared 510(K)
- K032972AEROCHAMBER MAX VALVED HOLDING CHAMBER2Cleared 510(K)
- K031908MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)2Cleared 510(K)
- K032849AERONEB GO NEBULIZER, MODEL AG-AG20002Cleared 510(K)
- K032809HOSPITAL SPACER2Cleared 510(K)
- K030374SONIK LDI 20 AIR2Cleared 510(K)
- K023602SMALL VOLUME NEBULIZER2Cleared 510(K)
- K021742GALEMED NEB-EASY NEBULIZER2Cleared 510(K)
- K02144356 SERIES JET NEBULIZER2Cleared 510(K)
- K020357800 SERIES EASYNEB NEBULIZER2Cleared 510(K)
- K020932DEVILBISS PULMO-AIDE COMPACT COMPRESSOR2Cleared 510(K)
- K021175AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP60002Cleared 510(K)
- K020944VORTEX VALVED HOLDING CHAMBER2Cleared 510(K)
- K014056SALTER LABS MODIFIED NEBUTECH NEBULIZER2Cleared 510(K)
- K012939AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER2Cleared 510(K)
- K012006MEDICAL DEPOT POWER NEB 12Cleared 510(K)
- K002543COMOACT ULTRASONIC NEBULIZER, MODEL 30602Cleared 510(K)
- K010680CT SPACER2Cleared 510(K)
- K002831VEGA ULTRASONIC NEBULIZER2Cleared 510(K)
- K003344MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 22Cleared 510(K)
- K002153ULTRASONIC NEBULIZER, MODEL NE-5202Cleared 510(K)
- K993101LITEAIRE2Cleared 510(K)
- K003022AERONEB PORTABLE NEBULIZER2Cleared 510(K)
- K992831AERONEB II, MODEL APN 2002Cleared 510(K)
- K001137AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)2Cleared 510(K)
- K000543CONTEMPRO-MIST2Cleared 510(K)
- K990435BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-1001002Cleared 510(K)
- K993492DEVILBISS NEBULIZER MODEL 8002Cleared 510(K)
- K993199POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER2Cleared 510(K)
- K994352SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 418962Cleared 510(K)
- K990897NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER2Cleared 510(K)
- K991355METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE2Cleared 510(K)
- K992285SALTER AIRE COMPRESSOR2Cleared 510(K)
- K993558EZFLOW MAX, MODEL 10072Cleared 510(K)
- K992722PRIMEAIRE2Cleared 510(K)
- K992643MODEL IRC 1001 AEROSOL COMPRESSOR2Cleared 510(K)
- K992986SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER2Cleared 510(K)
- K992917AEROCHAMBER PLUS VALVED HOLDING CHAMBER2Cleared 510(K)
- K992038POCKETSPACER2Cleared 510(K)
- K980024SHINMED MODEL SW-966 ULTRASONIC NEBULIZER2Cleared 510(K)
- K991685HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR2Cleared 510(K)
- K991788SALTER LABS PEP DEVICE2Cleared 510(K)
- K984085RITEFLO SPACER2Cleared 510(K)
- K991725SIDESTREAM NEBULIZER2Cleared 510(K)
- K990384EZFLOW CONTINUOUS NEBULIZER,MODEL 10052Cleared 510(K)
- K982722AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD2Cleared 510(K)
- K990185MDILOG, MODEL MDC-5122Cleared 510(K)
- K990506MABIS NB-02 ULTRASONIC NEBULIZER2Cleared 510(K)
- K982181TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER2Cleared 510(K)
- K971981LS SERIES 200 FLOVISION SYSTEM2Cleared 510(K)
- K983403SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER2Cleared 510(K)
- K981249METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D2Cleared 510(K)
- K983736ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER2Cleared 510(K)
- K982043BRENEB2Cleared 510(K)
- K981772HALOLITE AAD SYSTEM2Cleared 510(K)
- K983002MYSTIQUE ULTRASONIC NEBULIZER2Cleared 510(K)
- K982179TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER2Cleared 510(K)
- K982408AEROTEE, MODEL # 10012Cleared 510(K)
- K981944BREATHERITE2Cleared 510(K)
- K981167STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT2Cleared 510(K)
- K98007456 SERIES AEROSOL GENERATOR2Cleared 510(K)
- K9808293ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP2Cleared 510(K)
- K980407HOPE NEBULIZER2Cleared 510(K)
- K973532STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR2Cleared 510(K)
- K974379ULTRANEB2Cleared 510(K)
- K972657ULTRAMIST 20002Cleared 510(K)
- K9740560.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP2Cleared 510(K)
- K973468MODEL IRC 1199 SCOUT NEBULIZER2Cleared 510(K)
- K970844ATOMISOR2Cleared 510(K)
- K972778DEY VIAL SODIUM CHLORIDE 3%2Cleared 510(K)
- K971808SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES2Cleared 510(K)
- K972467STERILE WATER FOR INHALATION, USP2Cleared 510(K)
- K972466SODIUM CHLORIDE INHALATION SOLUTION, USP2Cleared 510(K)
- K972371ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR2Cleared 510(K)
- K970344MDILOG, MODEL MDC-5112Cleared 510(K)
- K971933PORT-NEB2Cleared 510(K)
- K972237HAND HELD MEDISPACER2Cleared 510(K)
- K970542MASTER NEB II2Cleared 510(K)
- K963793OPTIVENT2Cleared 510(K)
- K970289COMPRESSOR/NEBULIZER #36502Cleared 510(K)
- K970035JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-0092Cleared 510(K)
- K970010FPT NEBULIZER2Cleared 510(K)
- K952910THE SWIRLER NEBULIZER2Cleared 510(K)
- K962534THERA-MIST NEBULIZER MODEL-P30002Cleared 510(K)
- K963917HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT2Cleared 510(K)
- K962872RESPIFLO2Cleared 510(K)
- K962874RESPIFLO/S2Cleared 510(K)
- K964994CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR2Cleared 510(K)
- K962438MISTY OX TURBOHEATER2Cleared 510(K)
- K9640783050 SPORT-NEB2Cleared 510(K)
- K960854SIEMENS SERVO ULTRA NEBULIZER 3452Cleared 510(K)
- K963910HEART NEBULIZER #1006092Cleared 510(K)
- K963924LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F702Cleared 510(K)
- K962879SALTERLABS 8660 SERIES NEBULIZER2Cleared 510(K)
- K962822OPTICHAMBER2Cleared 510(K)
- K962085SALTER LABS 8990 SERIES NEBULIZER2Cleared 510(K)
- K962072PRONEB TURBO COMPRESSOR MODEL 38V02002Cleared 510(K)
- K962161BAXTER NEBULIZER CAP MODEL 2D08682Cleared 510(K)
- K961973DHD ACE WITH MASK KIT2Cleared 510(K)
- K961476SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)2Cleared 510(K)
- K955104HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER2Cleared 510(K)
- K960675WALKHALER PORTABLE COMPRESSOR MODEL 45F702Cleared 510(K)
- K960397MEDICATOR AEROSOL DRUG DELIVERY SYSTEM2Cleared 510(K)
- K955805DUAL SPRAY MINISPACER2Cleared 510(K)
- K952326PULMOMIST2Cleared 510(K)
- K952249JET NEBULIZER2Cleared 510(K)
- K941627A&D UN-231 ULTRASONIC HANDY NEBULIZER2Cleared 510(K)
- K954327MEDOX CHAMPION COMPACT NEBULIZER2Cleared 510(K)
- K952893THE SWIRLER AEROSOL SYSTEM2Cleared 510(K)
- K933961MARSAM MODEL 2000 NEBULIZER2Cleared 510(K)
- K943717MASTER-NEB NEBULIZER COMPRESSOR SYSTEM2Cleared 510(K)
- K953206DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)2Cleared 510(K)
- K950290MEDI - PUMP2Cleared 510(K)
- K946095DEVILBISS MODEL 55002Cleared 510(K)
- K951259ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 123002Cleared 510(K)
- K950867MEDI - PUMP2Cleared 510(K)
- K9439903000 AEROSOL TWO2Cleared 510(K)
- K935540PARI-MASTER MODIFICATION2Cleared 510(K)
- K944020AIRSEP NEWLIFE AIR OUTLET OPTION2Cleared 510(K)
- K9424443002 AEROMAX2Cleared 510(K)
- K9422084003 AEROLITE2Cleared 510(K)
- K950206FISONEB(R) II2Cleared 510(K)
- K942384ENDURANCE R30002Cleared 510(K)
- K942350CAREPAK2Cleared 510(K)
- K944152PARI BABY2Cleared 510(K)
- K943600UNIHEART2Cleared 510(K)
- K940257HAND-HELD NEBULIZER2Cleared 510(K)
- K944643AUTONEB ACCESSORY CROSS (AAC)2Cleared 510(K)
- K935955DOSER2Cleared 510(K)
- K935693AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT2Cleared 510(K)
- K934749FREEWAY LITE NEBULIZER COMPRESSOR2Cleared 510(K)
- K921273EASIMIST ULTRASONIC NEBULIZER2Cleared 510(K)
- K926280STANDARD NEBULIZER HEATER2Cleared 510(K)
- K933090EZ-SPACER2Cleared 510(K)
- K933535VENTSTREAM DRUG NEBULIZER2Cleared 510(K)
- K930574AEROCHAMBER W/MASK, MODIFIED2Cleared 510(K)
- K933915VENTI-GENTLE-HALER(TM)2Cleared 510(K)
- K923559STERI-CATH MDI2Cleared 510(K)
- K930525MICRO MIST(TM) NEBULIZER2Cleared 510(K)
- K926455PARI FILTER/VALVE SET2Cleared 510(K)
- K924667AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)2Cleared 510(K)
- K926301ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO2Cleared 510(K)
- K930947PROMENADE2Cleared 510(K)
- K930949VOYAGE2Cleared 510(K)
- K924649SOFT-MIST(TM)2Cleared 510(K)
- K931603MILLIPORE RT-100 AEROSOL RETENTION FILTER2Cleared 510(K)
- K924535THAYER HAND HELD M.K.I. HOLDING CHAMBER2Cleared 510(K)
- K923888DEVILBISS MODEL 5650 PULMO-AIDE2Cleared 510(K)
- K923698BETAMIST 22Cleared 510(K)
- K926055THE MILLER NEBULIZER SYSTEM2Cleared 510(K)
- K923324PRECISION MIST COMPRESSOR2Cleared 510(K)
- K924684MICROFLOW2Cleared 510(K)
- K921809COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)2Cleared 510(K)
- K913096SAM SC2Cleared 510(K)
- K913095SAM LS2Cleared 510(K)
- K922187COMPACT SPACER2Cleared 510(K)
- K924123SIDESTREAM DISPOSABLE2Cleared 510(K)
- K924081LUMISONIC2Cleared 510(K)
- K923690MINI HEART2Cleared 510(K)
- K923596HEART NEBULIZER2Cleared 510(K)
- K921339HAND-E-BREATH2Cleared 510(K)
- K923024NE-U04/NE U04F2Cleared 510(K)
- K922923NE-U072Cleared 510(K)
- K914772MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 20012Cleared 510(K)
- K915075NEBULIZER (DIRECT PATIENT INTERFACE)2Cleared 510(K)
- K920443MININEB2Cleared 510(K)
- K920332HEART NUBULIZER2Cleared 510(K)
- K915211MICROCHAMBER2Cleared 510(K)
- K914836OMRON COMPRESSOR NEBULIZER- MODEL NE-C092Cleared 510(K)
- K914152SIDESTREAM DRUG NEBULIZER2Cleared 510(K)
- K914465AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P320002Cleared 510(K)
- K914283THAYER EXPANSION CHAMBER METERED DOSE INHALER2Cleared 510(K)
- K912805PARI-MASTER2Cleared 510(K)
- K913326DHD METERED DOSE INHALER (MDI) SPACER2Cleared 510(K)
- K913316DEVILBISS MODEL 7427D2Cleared 510(K)
- K911192DP 1002Cleared 510(K)
- K913015HEART NEBULIZER FLOWMETER ADAPTOR2Cleared 510(K)
- K911807METERED DOSE INHALER (MDI) SPACER2Cleared 510(K)
- K911422DRUG NEBULIZERS2Cleared 510(K)
- K913220AEROSOL MASKS, 81426, 81476, 81490 & 814922Cleared 510(K)
- K911785RHINO-GUARD2Cleared 510(K)
- K911759VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER2Cleared 510(K)
- K912566MINITROP AEROSOL UNIT2Cleared 510(K)
- K913000HEART NEBULIZER POLE CLAMP2Cleared 510(K)
- K911896DEVILBISS MODEL 50002Cleared 510(K)
- K904398WATER COLUMN RELIEF VALVE2Cleared 510(K)
- K904717MICRO-VENT NEBULIZER SYSTEM2Cleared 510(K)
- K904718AERO-GEN NUBULIZER SYSTEM2Cleared 510(K)
- K903499MINI-MICRON CIRCUIT2Cleared 510(K)
- K904715OXYGEN/AIR TUBING2Cleared 510(K)
- K904716AERO-GEN NEBULIZER2Cleared 510(K)
- K903580MICRO-MISTER2Cleared 510(K)
- K904196MICRO-MIST NEBULIZER2Cleared 510(K)
- K896375PREEMICARE NEBUTECH NEBULIZER SYSTEM2Cleared 510(K)
- K903413MICROSPACER TM2Cleared 510(K)
- K901315AEROMIST II NEBULIZER2Cleared 510(K)
- K900273TRACH CARE MDI ADAPTER2Cleared 510(K)
- K896536PHARMATRONICS NEBULIZER2Cleared 510(K)
- K900783MDI ADAPTOR2Cleared 510(K)
- K901362ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE2Cleared 510(K)
- K901301STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL2Cleared 510(K)
- K901114MEDISONIC HUMDIFIER/INHALER2Cleared 510(K)
- K900470IN-THE NEBULIZER2Cleared 510(K)
- K900228H.E.A.R.T. NEBULIZER2Cleared 510(K)
- K896923INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT2Cleared 510(K)
- K896984PARI I.S.-22Cleared 510(K)
- K896696(HEART) NEBULIZER2Cleared 510(K)
- K896192MEDISONIC PNEU-NEB2Cleared 510(K)
- K895913STANDARD NEBULIZER HEATER2Cleared 510(K)
- K894961MEDISONIC ULTRA-SONIC INHALER2Cleared 510(K)
- K895231CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER2Cleared 510(K)
- K894138MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD2Cleared 510(K)
- K893942THERA-MIST(TM) NEBULIZER, MODEL 300002Cleared 510(K)
- K884803AEROCHAMBER M.V.2Cleared 510(K)
- K884947HAND HELD NEBULIZER SYSTEM2Cleared 510(K)
- K882936ADJUSTABLE ENTRAINMENT NEBULIZER2Cleared 510(K)
- K881648TRANSFER CONTAINER HUMIDIFIER2Cleared 510(K)
- K882935NEBULIZER HEATER2Cleared 510(K)
- K884359UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.2Cleared 510(K)
- K884051DSM-1 DOSIMETER2Cleared 510(K)
- K875134OMRON ULTRASONIC NEBULIZER NE-U062Cleared 510(K)
- K883964AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER2Cleared 510(K)
- K882953HYDRAMED BY LECHLER2Cleared 510(K)
- K881935MICROCIRRUS MEDICAL NEBULIZER2Cleared 510(K)
- K880473AERO-MIST NEBULIZER HEATER2Cleared 510(K)
- K880304INSPIRON NEBULO BASIC EXTERNAL HEATER2Cleared 510(K)
- K873521BRONCHODILATOR TEE - 9056 SERIES2Cleared 510(K)
- K880411DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE2Cleared 510(K)
- K874047ASTHMAKIT2Cleared 510(K)
- K874082PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT2Cleared 510(K)
- K874041DEVILBISS MODEL 8500D2Cleared 510(K)
- K874395RESPIRGARD II NEBULIZER SYSTEM2Cleared 510(K)
- K873930AEROSOL DELIVERY SYSTEM (AERO-TECH II)2Cleared 510(K)
- K873395HOYER SOLVET2Cleared 510(K)
- K871427(SPAG) MODEL SPAG-2 6000 SERIES2Cleared 510(K)
- K870051SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE2Cleared 510(K)
- K872826ULTRA-NEB 99 ULTRASONIC NEBULIZER2Cleared 510(K)
- K871293SERVO NEBULIZER 945 SIEMENS-ELEMA AB2Cleared 510(K)
- K864466OMRON ULTRASONIC NEBULIZER MODEL NE-UO52Cleared 510(K)
- K851436NEBULAIRE (IRC 1040) NEBULIZER PUMP2Cleared 510(K)
- K851074VARIABLE NEBULIZER HEATER2Cleared 510(K)
- K800023LUNG AEROSOL UNIT2Cleared 510(K)
- K834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN2Cleared 510(K)
- K833922BRETHANCER, DRUG DELIVERY SYS-INHAL2Cleared 510(K)
- K832898NEBULIZER ACCESSORY FOR SERVO VENTILL2Cleared 510(K)
- K832086USE 77 ULTRASONIC NEBULIZER2Cleared 510(K)
- K831270DISPOS. MEDICATION NEBULIZER2Cleared 510(K)
- K831162ENERGETIC HI-HUM AERSOL UNIT2Cleared 510(K)
- K830943PREFILLED RESPIRATORY THERAPY VIAL2Cleared 510(K)
- K830895SINGLE USE NEBULIZER, ADJUST. AIR-2Cleared 510(K)
- K821129AIRLIFE NEBULIZER HEATER2Cleared 510(K)
- K821191STER-O-MIST 1000 ML2Cleared 510(K)
- K820952OPTI-MIST2Cleared 510(K)
- K820227STER-O-DOSE2Cleared 510(K)
- K810217NEBULIZER HEATER2Cleared 510(K)
- K810218PREFILLED NEBULIZER2Cleared 510(K)
- K802477MISTY NEBULIZER2Cleared 510(K)
- K801875CIRCUITS, BREATHING W/CONNECTORS, ADAPT2Cleared 510(K)
- K800830SIEMENS-ELECTROGERATE GMBH MICRO-INHALER2Cleared 510(K)
- K800562DISPOSABLE HAND HELD NEBULIZER2Cleared 510(K)
- K8002940.45% SODIUM CHLORIDE SOL./RESP. THERAPY2Cleared 510(K)
- K8002950.9% SODIUM CHLORIDE SOL./RESP. THERAPY2Cleared 510(K)
- K800083NEBULIZER TUBING SET2Cleared 510(K)
- K792364TEE ADAPTER2Cleared 510(K)
- K792218MISTY BEBULIZER2Cleared 510(K)
- K791820I.P.P.B. MANIFOLDS & NEB. SING. & DBL2Cleared 510(K)
- K791536DISPOSABLE MEDICATION NEBULIZER2Cleared 510(K)
- K791445TWO-PIECE IPPB MANIFOLD MACHINES2Cleared 510(K)
- K791443TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE2Cleared 510(K)
- K791444UNIVERSAL TWO-PIECE MACHINES2Cleared 510(K)
- K791218INHALATION OPERATED NEBULIZER CODE2Cleared 510(K)
- K790892MISTY NEBULIZER2Cleared 510(K)
- K791089SHERWOOD NEBULIZER KIT2Cleared 510(K)
- K790982INSPIRON NEBULO TM 28 NEBULIZER KIT2Cleared 510(K)
- K791042I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL2Cleared 510(K)
- K790926NEBULIZER WITH MOUTHPIECE AND TEE2Cleared 510(K)
- K790924NEBULIZER NO. M-1752Cleared 510(K)
- K790925NEBULIZER WITH 4-WAY T NO M-1742Cleared 510(K)
- K790152MANIFOLD, UNIVERSAL I.P.P.B2Cleared 510(K)
- K790153MANIFOLD, W/CORRUGATED TUBING2Cleared 510(K)
- K790154MANIFOLD, FOR DOUBLE SUPPLY2Cleared 510(K)
- K781485PATIENT CIRCUIT MANIFOLD2Cleared 510(K)
- K781542HEATED NEBULIZER2Cleared 510(K)
- K781467U-FLOAT VALVE 2D90232Cleared 510(K)
- K780668SOLUTIONS FOR RESPIRATORY THERAPY2Cleared 510(K)
- K780456NEBULIZER HEATER2Cleared 510(K)
- K7804062C7153 NEBULIZER CAP2Cleared 510(K)
- K780119NEBULIZER, DISP, 2D08152Cleared 510(K)
- K780264NEBULIZATION KIT & ADAPTER KIT2Cleared 510(K)
- K772296INSPIRON MANIFOLD2Cleared 510(K)
- K772294INSPIRON MANIFOLD (DOUBLE)2Cleared 510(K)
- K772295INSPIRON MANIFOLD (SINGLE)2Cleared 510(K)
- K772348NEBULIZER ADAPTER2Cleared 510(K)
- K772222NEBULIZER SET-2C71052Cleared 510(K)
- K772072MANIFOLD & NEBU. FOR DOUB. LINE MACH.2Cleared 510(K)
- K772071MANIFOLD & NEBU. FOR SINGLE LINE MACH.2Cleared 510(K)
- K772070VENTILATOR SETUP, VOLUME2Cleared 510(K)
- K772068MANIFOLD & NEBULIZER, UNIVERSAL2Cleared 510(K)
- K771550MRT DISPENSOR2Cleared 510(K)
- K771105NEBULIZER, MOLEL 503, PART #170682Cleared 510(K)
- K771061ODUFLEX AEROSOL SET2Cleared 510(K)
- K770664NEBULIZER2Cleared 510(K)
- K770828NEBULIZER HEATER2Cleared 510(K)
- K770633BRACKET BE 122-12Cleared 510(K)
- K761300NEBULIZER CONTROL UNIT2Cleared 510(K)
- K761298PRE-FILLED DISPOSABLE NEBULIZER2Cleared 510(K)
- K761299DISPOSABLE NEBULIZER2Cleared 510(K)
- K760964ADDI-MIST2Cleared 510(K)
- K760845SOLO-SPHERE HEATER2Cleared 510(K)
- K760585U-MID PREFILLED NEBULIZER2Cleared 510(K)
- K760489NEBULIZER, HANDHELD (T UP-DRAFT)2Cleared 510(K)
- K760442NEBULIZER ADAPTER (AERMIST)2Cleared 510(K)
- K760335NEBULIZER, MICRO (ADDI-MIST)2Cleared 510(K)
- K760095RESPIRIZOR2Cleared 510(K)
- CAGCirculator, Breathing-Circuit2Product Code
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)1Product Code
- CALLaryngoscope, Non-Rigid1Product Code
- CAOAirway, Esophageal (Obturator)2Product Code
- CATCannula, Nasal, Oxygen1Product Code
- CAWGenerator, Oxygen, Portable2Product Code
- CAZAnesthesia Conduction Kit2Product Code
- CBFChamber, Hyperbaric2Product Code
- CBGSpreader, Cuff1Product Code
- CBHDevice, Fixation, Tracheal Tube1Product Code
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2Product Code
- CBKVentilator, Continuous, Facility Use2Product Code
- CBLAbsorbent, Carbon-Dioxide1Product Code
- CBNApparatus, Gas-Scavenging2Product Code
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)2Product Code
- CBPValve, Non-Rebreathing2Product Code
- MODAccessory To Continuous Ventilator (Respirator)2Product Code
- CCOBed, Rocking, Breathing Assist2Product Code
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1Product Code
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia2Product Code
- CCWLaryngoscope, Rigid1Product Code
- EPEBrush, Cleaning, Tracheal Tube1Product Code
- FNCTent, Pediatric Aerosol2Product Code
- FOGHood, Oxygen, Infant1Product Code
- JAYSupport, Breathing Tube1Product Code
- JOHTube Tracheostomy And Tube Cuff2Product Code
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)1Product Code
- KGBMask, Oxygen, Non-Rebreathing1Product Code
- KHAMask, Scavenging1Product Code
- LNZChanger, Tube, Endotracheal2Product Code
- MIANeedle, Spinal, Short Term2Product Code
- MNSVentilator, Continuous, Non-Life-Supporting2Product Code
- MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use2Product Code
- MRNApparatus, Nitric Oxide Delivery2Product Code
- MROApparatus, Nitric Oxide, Backup Delivery2Product Code
- MZTDevice, Heimlich Maneuver Assist2Product Code
- NFBConserver, Oxygen2Product Code
- NHJDevice, Positive Pressure Breathing, Intermittent2Product Code
- NHKResuscitator, Manual, Non Self-Inflating2Product Code
- NMATube, Tracheal, Reprocessed2Product Code
- NMCMask, Ventilator, Non-Continuous, Reprocessed2Product Code
- NMRNeedle, Spinal, Short Term, Reprocessed2Product Code
- NNHNeedle, Conduction, Anesthesia, Reprocessed2Product Code
- NOUContinuous, Ventilator, Home Use2Product Code
- NQYVentilator, Continuous, Minimal Ventilatory Support, Home Use2Product Code
- NVOSpacer, Direct Patient Interface2Product Code
- NVPHolding Chambers, Direct Patient Interface2Product Code
- NXATracheotomy Care Kit2Product Code
- OBNHumidifier, Respiratory, Mask (Direct Patient Interface)2Product Code
- OFQAnesthesia Kit2Product Code
- OFTSpinal Epidural Anesthesia Kit2Product Code
- OFUSpinal Anesthesia Kit2Product Code
- OFVRegional Anesthesia Kit2Product Code
- OGABrachial Plexus Anesthesia Kit2Product Code
- OGBCaudal Anesthesia Kit2Product Code
- OGCContinuous Brachial Plexus Block Tray2Product Code
- OGDCustom Anesthesia Tray2Product Code
- OGEEpidural Anesthesia Kit2Product Code
- OGFGlossopharyngeal Anesthesia Kit2Product Code
- OGGHumidifier Nebulizer Kit2Product Code
- OGHLaryngoscope Kit1Product Code
- OGINasal Endotracheal Tube Holder Kit1Product Code
- OGJNerve Block Tray2Product Code
- OGLOxygen Administration Kit2Product Code
- OLFMedevac Use Oxygen Generator2Product Code
- ONZMechanical Ventilator2Product Code
- OQUAirway Monitoring System2Product Code
- PHSOral Airway Assist1Product Code
- PMBExternal Airway2Product Code
- QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device2Product Code
- QBYPositive Airway Pressure System2Product Code
- QCXRetrograde Intubation Set2Product Code
- OZRIntraoral Pressure Gradient Device2Product Code
- QFBIsocapnic Ventilation Device2Product Code
- SDSCompression-Based Airway Clearance Device2Product Code
- SDTIntra-Pulmonary Percussive Vibration (Ipv) Devices2Product Code
- SFPVentilator-Compatible Nebulizer2Product Code
- SGRNoninvasive Positive Airway Pressure System, Facility Use2Product Code
- Subpart G—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BreatheSuite MDI V1
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K203155
- 510(k) Type
- Traditional
- Applicant
- Breathesuite, Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/17/2021
- Days to Decision
- 330 days
- Submission Type
- Summary