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
- K243690SonoMSK2Cleared 510(K)
- K243682SonoPlex STIM; SonoPlex II2Cleared 510(K)
- K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture2Cleared 510(K)
- K243525SonoTAP and SonoTAP II2Cleared 510(K)
- K241953SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology2Cleared 510(K)
- K241954SonoBlock; SonoBlock II2Cleared 510(K)
- K240253Reach Needle2Cleared 510(K)
- K212982Medispine - Spinal Needle, Glospine - Spinal Needle2Cleared 510(K)
- K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle2Cleared 510(K)
- K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle2Cleared 510(K)
- K203668RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles2Cleared 510(K)
- K212328DiscCath Needle Set2Cleared 510(K)
- K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle2Cleared 510(K)
- K192914Stimuplex Onvision System2Cleared 510(K)
- K191290Ancora Nerve Block Catheter Set2Cleared 510(K)
- K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)2Cleared 510(K)
- K183316Dr J Spinal and Epidural Needles2Cleared 510(K)
- K172823Portex NRFit Epidural Needles2Cleared 510(K)
- K173155Pakter Curved Needle Set2Cleared 510(K)
- K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters2Cleared 510(K)
- K173110GRAFTSITE2Cleared 510(K)
- K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle2Cleared 510(K)
- K170112IMD's Lumbar Puncture Needle2Cleared 510(K)
- K171968EchoGlo Needle2Cleared 510(K)
- K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles2Cleared 510(K)
- K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford2Cleared 510(K)
- K170435NerveGuard NRFit, NerveGuard LUER2Cleared 510(K)
- K163216Pinpoint GT Needles2Cleared 510(K)
- K163435Entellus Medical Reinforced Anesthesia Needle2Cleared 510(K)
- K160297Tuohy NRFit2Cleared 510(K)
- K160295SPROTTE NRFit, Quincke NRFit2Cleared 510(K)
- K160296SPROTTE SPECIAL NRFit2Cleared 510(K)
- K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles2Cleared 510(K)
- K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle2Cleared 510(K)
- K151072Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit2Cleared 510(K)
- K150266Remington Medical Inc. Tuohy Epidural Needles2Cleared 510(K)
- K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle2Cleared 510(K)
- K141126UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE2Cleared 510(K)
- K133632PERICAN ULTRA2Cleared 510(K)
- K131006ANESTHESIA CONDUCTION NEEDLES2Cleared 510(K)
- K121812SONIXGPS2Cleared 510(K)
- K120475ANESTHESIA CONDUCTION NEEDLES2Cleared 510(K)
- K121846CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE2Cleared 510(K)
- K113207SONO TAP, TUOHY SONO2Cleared 510(K)
- K112515PENCAN SPINAL NEEDLE2Cleared 510(K)
- K111374SONO-SERIES CORNERSTONE TECHNIQUE2Cleared 510(K)
- K110194MEDLINE EPIDURAL AND SPINAL NEEDLES2Cleared 510(K)
- K101728FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE2Cleared 510(K)
- K100241CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 3316802Cleared 510(K)
- K093209FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE2Cleared 510(K)
- K091758BD SPINAL NEEDLE 27G2Cleared 510(K)
- K091818LAURIMED SPINAL INJECTION SYSTEM2Cleared 510(K)
- K090261PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G2Cleared 510(K)
- K083909SPINAL INJECTION SYSTEM2Cleared 510(K)
- K082772STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC181502Cleared 510(K)
- K081864PROLONG2Cleared 510(K)
- K080603HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED2Cleared 510(K)
- K081446BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 4052372Cleared 510(K)
- K080140LAURIMED SPINAL INJECTION SYSTEM2Cleared 510(K)
- K073222MODIFICATION TO:SPECIALTY NEEDLES2Cleared 510(K)
- K073516DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR2Cleared 510(K)
- K072005RK EPIDURAL NEEDLE2Cleared 510(K)
- K063350DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE2Cleared 510(K)
- K070354IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)2Cleared 510(K)
- K063380ECHOSTIM FACET TIP2Cleared 510(K)
- K063071DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B2Cleared 510(K)
- K061394SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)2Cleared 510(K)
- K061210FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B2Cleared 510(K)
- K053318RX EPIDURAL NEEDLE2Cleared 510(K)
- K050499PROBLOC, HN SERIES AND PROLONG, PL SERIES2Cleared 510(K)
- K043500FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE2Cleared 510(K)
- K043467FLEXIBLE SPINAL NEEDLE2Cleared 510(K)
- K042979MODIFICATION TO: PLEXALONG SETS2Cleared 510(K)
- K040965PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES2Cleared 510(K)
- K041843PENCIL POINT NEEDLE2Cleared 510(K)
- K032981SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-092Cleared 510(K)
- K030618WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE2Cleared 510(K)
- K030562TUOHY EPIDURAL NEEDLE2Cleared 510(K)
- K023218MODIFICATION TO PLEXOLONG SETS2Cleared 510(K)
- K020934DR. JAPAN FACIL POINT SPINAL NEEDLE2Cleared 510(K)
- K022029QUINCKE SPINAL NEEDLE2Cleared 510(K)
- K013892LUTZ NEEDLE2Cleared 510(K)
- K013610PERIFIX SAFETY EPIDURAL NEEDLES2Cleared 510(K)
- K013231AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L2Cleared 510(K)
- K011122BALLPEN SPINAL NEEDLE W/WO INTRODUCER2Cleared 510(K)
- K011209MANAN SPRITACRE SPINAL NEEDLES2Cleared 510(K)
- K002405SPINAL EPIDURAL NEEDLES2Cleared 510(K)
- K990519PHOENIX EPIDURAL & SPINAL NEEDLES2Cleared 510(K)
- K993619CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK2Cleared 510(K)
- K000722UNIPOLAR NEEDLES2Cleared 510(K)
- K000495BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES2Cleared 510(K)
- K983620MANAN SPINAL NEEDLES2Cleared 510(K)
- K980536EPIDURAL NEEDLE2Cleared 510(K)
- K972595ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER2Cleared 510(K)
- K951928DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)2Cleared 510(K)
- K961151SPINAL NEEDLES2Cleared 510(K)
- K961152TUOHY EPIDURAL NEEDLES2Cleared 510(K)
- K962886ANESTHESIA CONDUCTION NEEDLE2Cleared 510(K)
- K961444GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)2Cleared 510(K)
- K940061POLYMEDIC SPINAL NEEDLE AND INTRODUCER2Cleared 510(K)
- K952275GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB2Cleared 510(K)
- K951949CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.2Cleared 510(K)
- K942863EPIDURAL NEEDLE2Cleared 510(K)
- K945965ATRAUMATIC PENCIL POINT SPINAL NEEDLE2Cleared 510(K)
- K946047HOLGRATH METAL-HUB, EPIDURAL NEEDLE2Cleared 510(K)
- K950820SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE2Cleared 510(K)
- K944905HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE2Cleared 510(K)
- K944908HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE2Cleared 510(K)
- K944907HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE2Cleared 510(K)
- K944906HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE2Cleared 510(K)
- K951312MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)2Cleared 510(K)
- K951411MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)2Cleared 510(K)
- K951265MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)2Cleared 510(K)
- K943649GERTIE MARX NEEDLE2Cleared 510(K)
- K935255ELDOR NEEDLE2Cleared 510(K)
- K932569PENCIL POINT SPINAL NEEDLE AND TRAY2Cleared 510(K)
- K932400ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY2Cleared 510(K)
- K931644GERTIE MARX NEEDLE2Cleared 510(K)
- K921683PENCIL POINT SPINAL NEEDLE2Cleared 510(K)
- K925831MEDIZIV SPINAL NEEDLE SET2Cleared 510(K)
- K923003PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.2Cleared 510(K)
- K921288CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE2Cleared 510(K)
- K920305PHARMASEAL CLEAR HUB SPINAL NEEDLE2Cleared 510(K)
- K911221ATRAUMATIC SPECIAL SPROTTE NEEDLE2Cleared 510(K)
- K911202ATRAUMATIC STANDARD SPROTTE NEEDLE2Cleared 510(K)
- K911260ATRAUMATIC STANDARD SPROTTE NEEDLE2Cleared 510(K)
- K910652SPINAL TAP NEEDLE2Cleared 510(K)
- K901810MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE2Cleared 510(K)
- K901811ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE2Cleared 510(K)
- K910791CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING2Cleared 510(K)
- K903224EPISENSOR2Cleared 510(K)
- K89487816GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE2Cleared 510(K)
- K89487916GA X 10 MIDDLE SIZE BULLET POINT NEEDLE2Cleared 510(K)
- K89488016GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL2Cleared 510(K)
- K89488120GA X 7-1/2 THREADING BULLET POINT NEEDLE2Cleared 510(K)
- K894882INFILTRATION PUMP SYRINGE2Cleared 510(K)
- K895453SPINAL NEEDLE2Cleared 510(K)
- K853478PINPOINT NEEDLE2Cleared 510(K)
- K854816EPIDURAL ANESTHESIA NEEDLES2Cleared 510(K)
- K854149TSK STERIJECT STERILE EPIDURAL NEEDLE2Cleared 510(K)
- K851478VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 1832Cleared 510(K)
- K850111AIRES TUOHY NEEDLES 17GA. X 4 1/22Cleared 510(K)
- K843313TOP DISPOSABLE SPINAL NEEDLE2Cleared 510(K)
- K832126MICRO Z DISPOS. SPINAL ANESTH. NEEDLE2Cleared 510(K)
- K832233EPINEED EPIDURAL NEEDLE2Cleared 510(K)
- K823692SPINAL NEEDLE2Cleared 510(K)
- K822630MONOJECT PLASTIC HUB SPINAL NEEDLE2Cleared 510(K)
- K820047SPINOCAN SPINAL NEEDLE2Cleared 510(K)
- K813179PERICAN, EPIDURAL CANNULA2Cleared 510(K)
- K813236EPICAN EPIDURAL CANNULA, BEVEL ACCORD2Cleared 510(K)
- K813165PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE2Cleared 510(K)
- K811963VISITEC NEEDLE RANGE (ANESTHESIOLOGY)2Cleared 510(K)
- 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
- 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
SPROTTE SPECIAL NRFit
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K160296
- 510(k) Type
- Traditional
- Applicant
- Pajunk GmbH Medizintechnologie
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/27/2016
- Days to Decision
- 267 days
- Submission Type
- Summary