Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- BSEAnalyzer, Gas, Helium, Gaseous-Phase2Product Code
- BSIAlgesimeter, Powered2Product Code
- BTYCalculator, Predicted Values, Pulmonary Function2Product Code
- BXAAnalyzer, Gas, Water Vapor, Gaseous-Phase1Product Code
- BXLAlgesimeter, Manual1Product Code
- BXQRhinoanemometer (Measurement Of Nasal Decongestion)2Product Code
- BXRMeter, Airway Pressure (Inspiratory Force)2Product Code
- BXWCalibrator, Volume, Gas1Product Code
- BZCCalculator, Pulmonary Function Data2Product Code
- BZGSpirometer, Diagnostic2Product Code
- K241843TD-7301 Spirometer (TD-7301)2Cleared 510(K)
- K231416Air Next (NVD-02)2Cleared 510(K)
- K230501Spirobank Oxi2Cleared 510(K)
- K230178EasyOne Sky Spirometer2Cleared 510(K)
- K222525Alveoair Digital Spirometer2Cleared 510(K)
- K222443Air Smart Extra Spirometer2Cleared 510(K)
- K213754SpiroHome Personal, SpiroHome Clinic2Cleared 510(K)
- K213872ComPAS22Cleared 510(K)
- K212938Vitalograph Model 6000 Alpha2Cleared 510(K)
- K201493Spirometer2Cleared 510(K)
- K202837GoSpiro2Cleared 510(K)
- K201562Spirotrac2Cleared 510(K)
- K201002Safey Pocket Spirometer2Cleared 510(K)
- K200550Vitalograph Model 2120 In2itive eDiary2Cleared 510(K)
- K183089Air Next2Cleared 510(K)
- K183479Asthma Monitor AM32Cleared 510(K)
- K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option2Cleared 510(K)
- K190568ComPAS2 (Computerized Pulmonary Analysis System)2Cleared 510(K)
- K180011Pulmonx Chartis Tablet Console2Cleared 510(K)
- K163249GoSpiro2Cleared 510(K)
- K161536EasyOne Air Spirometer2Cleared 510(K)
- K161676Q13 SPIROLYSER®2Cleared 510(K)
- K160116SpiroScout2Cleared 510(K)
- K160253Vitalograph Model 6300 micro2Cleared 510(K)
- K150515IQSense Flow Sensor Mouthpiece2Cleared 510(K)
- K142642Vitalograph Model 6600 Compact2Cleared 510(K)
- K142812Vitalograph Model 6800 Pneumotrac2Cleared 510(K)
- K120577MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX2Cleared 510(K)
- K150137SpiroThor2Cleared 510(K)
- K141793PULMONE MINIBOXPFT 2.02Cleared 510(K)
- K141936MICROBLAB, MICROLOOP2Cleared 510(K)
- K142303NeumoFilt Ergo/Neumo Filt BiteOn2Cleared 510(K)
- K141546VITALOGRAPH MODEL 7000 SPIROTRAC2Cleared 510(K)
- K133428MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO2Cleared 510(K)
- K133722ASTHMA MONITOR AM32Cleared 510(K)
- K130322SPM-3002Cleared 510(K)
- K130784SPIROTEL2Cleared 510(K)
- K123896CCS-200 SPIROMETER2Cleared 510(K)
- K122384MINISPIR2Cleared 510(K)
- K120880ORBIT2Cleared 510(K)
- K113096MICRO I2Cleared 510(K)
- K103530SPIRODOC2Cleared 510(K)
- K111764CHARTIS CONSOLE2Cleared 510(K)
- K103575SPIRO PD2Cleared 510(K)
- K111587ALERKAN SPIROMETRY FILTER2Cleared 510(K)
- K100928MICRO DIARY SPIROMETER2Cleared 510(K)
- K101873MASTERSCREEN IOS2Cleared 510(K)
- K100687VITALOGRAPH HAND HELD SPIROMETER, MODEL 21202Cleared 510(K)
- K092813ASTRASONIC SPIROMETER, MODEL 29-80002Cleared 510(K)
- K093174SPIROPALM2Cleared 510(K)
- K092890ASTHMA MONITOR AM32Cleared 510(K)
- K090646CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-1052Cleared 510(K)
- K083199CHARTIS CONSOLE2Cleared 510(K)
- K090034EASY ON-PC SPIROMETER2Cleared 510(K)
- K090486ASTHMA MONITOR MODEL, AM12Cleared 510(K)
- K082478WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.622Cleared 510(K)
- K083233THE PFT FILTER2Cleared 510(K)
- K083879INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)2Cleared 510(K)
- K080921SPIRO-MASTER PC-10 SPIROMETRY SYSTEM2Cleared 510(K)
- K082766MODIFICATION TO MINISPIR, SPIROLAB III2Cleared 510(K)
- K073155VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)2Cleared 510(K)
- K072722MEDDORNA WIRELESS PRN SPIROMETER 1002Cleared 510(K)
- K072979SPIROBANK G2Cleared 510(K)
- K061571ASTRA 3002Cleared 510(K)
- K062913ASTRAGUARD PULMONARY FUNCTION FILTER2Cleared 510(K)
- K061283PULMOLIFE2Cleared 510(K)
- K061875MINISPIR; SPIROLAB III2Cleared 510(K)
- K061712SPIROBANK II2Cleared 510(K)
- K052140SPIROLAB, SPIROLAB II2Cleared 510(K)
- K052176FLOWHANDY ZAN100 USB2Cleared 510(K)
- K051572KOKO LEGEND2Cleared 510(K)
- K052158WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE2Cleared 510(K)
- K051712MODEL 2800 PFT FILTER2Cleared 510(K)
- K042758POLYTECH PULMONARY FUNCTION FILTER2Cleared 510(K)
- K043528SPIROTEL2Cleared 510(K)
- K050424ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-502Cleared 510(K)
- K042595SPIRO'AIR2Cleared 510(K)
- K042058ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN2Cleared 510(K)
- K033518LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 1032Cleared 510(K)
- K033939FLOSENSE II, MODEL 29-80402Cleared 510(K)
- K031643SPIROTEL, MODEL 29-10202Cleared 510(K)
- K031102MICROLAB SPIROMETER2Cleared 510(K)
- K030917GEM; HAWK; EAGLE; MODELS 004110, 0044120, 0041302Cleared 510(K)
- K020102IQTEQ SPIROMETER2Cleared 510(K)
- K030464GEM, MODEL 0041102Cleared 510(K)
- K023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE2Cleared 510(K)
- K021200COMPAS2Cleared 510(K)
- K022276KOKOMATE2Cleared 510(K)
- K022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM2Cleared 510(K)
- K020280PULMOLAB EX671 EXERCISE TESTING SYSTEM2Cleared 510(K)
- K020004CLINDATALINK VERSION 1.0 FOR SPIROMETRY2Cleared 510(K)
- K013123EMS PULMONARY FUNCTION TESTING FILTER2Cleared 510(K)
- K010761SPL-50 SPIROLYSER2Cleared 510(K)
- K013812SPIROLAB II, MODEL 292Cleared 510(K)
- K013752COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)2Cleared 510(K)
- K011470SDI SB OFFICE, MODEL 29-2Cleared 510(K)
- K001528PC FLOW +2Cleared 510(K)
- K001278SENSAIRE DIAGNOSTIC SPIROMETER2Cleared 510(K)
- K002499BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE2Cleared 510(K)
- K000599VITALOGRAPH BASE STATION2Cleared 510(K)
- K993921NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 20012Cleared 510(K)
- K992823SPIROVIT SP-2, PNEUMOCHECK II2Cleared 510(K)
- K992743COLLINS CPL2Cleared 510(K)
- K984031SPIROVIT, MODEL SP-2502Cleared 510(K)
- K983909MIR SPIROBANK SPIROMETER2Cleared 510(K)
- K971336CAIRD TECHNOLOGY SPIROMETER2Cleared 510(K)
- K982956FLOWMATE II PLUS, MODEL #40002Cleared 510(K)
- K973138SPIROCARD2Cleared 510(K)
- K980876ASTHMA MONITOR AM22Cleared 510(K)
- K973456SPIROBANK PORTABLE PC BASED SPIROMETER2Cleared 510(K)
- K980441SPIROMETER MODEL NPB-5002Cleared 510(K)
- K965042MICRODL DIARYCARD SPIROMETER2Cleared 510(K)
- K963131GRASEBY ANDERSEN'S, INTEGRITY S7002Cleared 510(K)
- K963035MICRO SPIROMETER2Cleared 510(K)
- K960078ASTHMA MONITOR2Cleared 510(K)
- K953948SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO2Cleared 510(K)
- K954759FLOWMATE LTE2Cleared 510(K)
- K951718HM-SPIRO2Cleared 510(K)
- K954140MASTERSCREEN IOS2Cleared 510(K)
- K950223DISCOVERY GRAPHIC PORTABLE SPIROMETER2Cleared 510(K)
- K951227DX12Cleared 510(K)
- K946075VITALOGRAPH MODEL 21202Cleared 510(K)
- K946322POLYGRAM SOFTWARE2Cleared 510(K)
- K951367PORTA-SCREEN SPIROMETER2Cleared 510(K)
- K943546FUKUDA SANGYO MODEL SPIROANALYZER ST-1802Cleared 510(K)
- K944762PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE2Cleared 510(K)
- K944175ADAM SHELL THERMOCOUPLE ASSEMBLY2Cleared 510(K)
- K942779DISPOSABLE BACTERIOLOGICAL FILTER2Cleared 510(K)
- K932936L.A.P. II SPRIOMETRY SYSTEM2Cleared 510(K)
- K925459GS-MODULAR (GOLD STANDARD - MODULAR)2Cleared 510(K)
- K923988SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS2Cleared 510(K)
- K925085ESCORT SPIROMETER2Cleared 510(K)
- K923989SENSORMEDICS MODEL 6200 AUTOBOX DL2Cleared 510(K)
- K924413FLOWSCAN2Cleared 510(K)
- K921513SPIROLITE MODEL MSC-201 SPIROMETER2Cleared 510(K)
- K922428FUKUDA DENSHI MODEL SPIROSIFT SP-50002Cleared 510(K)
- K920877THE KEYSTONE SYSTEM2Cleared 510(K)
- K920111SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM2Cleared 510(K)
- K915451MULTISPIRO-SX2Cleared 510(K)
- K914272KOKO SPIROMETER2Cleared 510(K)
- K913396CANNULA STYLE THERMOCOUPLES2Cleared 510(K)
- K913395EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS2Cleared 510(K)
- K914205PFF-12Cleared 510(K)
- K920246SENSORMEDICS MODEL 922 SPIROMETER2Cleared 510(K)
- K914219AIRWAY THERMISTOR2Cleared 510(K)
- K914085HMS-50002Cleared 510(K)
- K912412VITALOGRAPH SPIROTRAC III2Cleared 510(K)
- K904625SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM2Cleared 510(K)
- K910950HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED2Cleared 510(K)
- K912234SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION2Cleared 510(K)
- K904200SPIROSIFT 500A2Cleared 510(K)
- K910452RESPI-PAK RT-PAK2Cleared 510(K)
- K904118SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.2Cleared 510(K)
- K904117SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.2Cleared 510(K)
- K904947PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE2Cleared 510(K)
- K900331TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)2Cleared 510(K)
- K901308SPIRO ANALYZER MODEL ST 2502Cleared 510(K)
- K900391FUKUDA DENSHI MODEL SPIROSIFT 30002Cleared 510(K)
- K901057SPIROMETRICS MODEL 2600 MIRO SPIROMETER2Cleared 510(K)
- K900673SERIAL FLOW2Cleared 510(K)
- K896300LDW SPIROMETRY SYSTEM2Cleared 510(K)
- K896924SPIROSCAN 40002Cleared 510(K)
- K895414MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM2Cleared 510(K)
- K895953WRIGHT VENTILOMETER VM-12Cleared 510(K)
- K897094MODIFIED SPIROSCAN 10002Cleared 510(K)
- K896120SCHILLER MODEL SP-100 SPIROVIT(TM)2Cleared 510(K)
- K896121SCHILLER MODEL SP-200 SPIROVIT(TM)2Cleared 510(K)
- K894556SPIROTEQ2Cleared 510(K)
- K895375MULTISPIRO2Cleared 510(K)
- K895253PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES2Cleared 510(K)
- K894997PRESTO DIAGNOSTIC SPIROMETER2Cleared 510(K)
- K894680RS232 FLOW SENSOR AND SOFTWARE PACKAGE2Cleared 510(K)
- K891672PUL-TRON 100K PROFESSIONAL SPIROMETER2Cleared 510(K)
- K890522PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER2Cleared 510(K)
- K881402629V SPIROMETER, PULMONARY FUNCTION ANALYZER2Cleared 510(K)
- K873562VITALOGRAPH-ALPHA2Cleared 510(K)
- K873817SPIRO ANALYZER ST-3002Cleared 510(K)
- K863134MULTISPIRO SA/1002Cleared 510(K)
- K863656SALTER VOLUCHEK 66002Cleared 510(K)
- K862023SPIROMATE AS-6002Cleared 510(K)
- K861227COLLINS PNEUMOTACH PFT SYSTEM2Cleared 510(K)
- K860522SPIROMETER, MODEL TS-1000, PART NO. SLZ75042Cleared 510(K)
- K853409SCREENMATE2Cleared 510(K)
- K854403MODEL 2120 SPIROSCREEN2Cleared 510(K)
- K854526VITALOGRAPH COMPACT2Cleared 510(K)
- K854062PALL PULMONARY FUNCTION FILTER2Cleared 510(K)
- K852092PB900 PB910 DIAGNOSTIC SPIROMETER2Cleared 510(K)
- K852677MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM2Cleared 510(K)
- K852307PULMONARY TEST SYSTEM FUDAC-302Cleared 510(K)
- K852337PNEUMOSCOPE2Cleared 510(K)
- K851135SPIRO SCAN2Cleared 510(K)
- K852308ST-460 SPIRO ANALYZER SPIROMETER2Cleared 510(K)
- K851620SPIROMED 22Cleared 510(K)
- K851277MICROSPIRO-SDS2Cleared 510(K)
- K843841ERGO-OXYSCREEN2Cleared 510(K)
- K844333SPIROMETRICS 2451 & SMI I2Cleared 510(K)
- K844226B-10002Cleared 510(K)
- K843996TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER2Cleared 510(K)
- K843984PM-80 PULMOTESTER2Cleared 510(K)
- K842536CDX802Cleared 510(K)
- K842372SPIROMATE AS-5002Cleared 510(K)
- K840972SPIROTECH ST-5502Cleared 510(K)
- K842041PULMONARY FUNCTION SYSTEM2Cleared 510(K)
- K840929FRC 85 SERIES SPIROMETER2Cleared 510(K)
- K840908CHESTAC-25F SPIROMETER2Cleared 510(K)
- K832401RESPIROMETER2Cleared 510(K)
- K831803PULMOMETER2Cleared 510(K)
- K840741PULMONARY FUNCTION TESTING STS2Cleared 510(K)
- K834475RESPIRODYNE PULMONARY FUNCTION TEST2Cleared 510(K)
- K832430FUKUNDA SANGYO UNITS ELECTRONIC SPIRO2Cleared 510(K)
- K832433AUTOMATIC SPIROMETER ST-2002Cleared 510(K)
- K832432SPIRO ANALYZER ST-100 AUTOMATIC SPIRO2Cleared 510(K)
- K832431FUKUNDA SANGYA UNITS PULMOTESTER PM602Cleared 510(K)
- K832185OHIO MODEL 922 SPIROMETER2Cleared 510(K)
- K831497SPIROMETRICS BREON 2400 & SMI 24002Cleared 510(K)
- K823770SPIROTECH ST-55002Cleared 510(K)
- K822861LIFELINE 4800-C DIGITAL SPIROMETER2Cleared 510(K)
- K820599AUTOSPIROMETER HI-4982Cleared 510(K)
- K820032VIT-O-METER2Cleared 510(K)
- K820036CXD 4002Cleared 510(K)
- K812039SPIROMETER 210/2112Cleared 510(K)
- K810437BREATH METER2Cleared 510(K)
- K791422MINISPIROMETER SP-12Cleared 510(K)
- K791177DISPIRO2Cleared 510(K)
- K780894AIRFLOMETER2Cleared 510(K)
- K770927PART NO. 66-003112Cleared 510(K)
- K770928PART NO. 66-001212Cleared 510(K)
- BZHMeter, Peak Flow, Spirometry2Product Code
- BZKSpirometer, Monitoring (W/Wo Alarm)2Product Code
- BZLComputer, Oxygen-Uptake2Product Code
- BZMCalculator, Pulmonary Function Interpretor (Diagnostic)2Product Code
- BZSStethoscope Head1Product Code
- BZTStethoscope, Esophageal, With Electrical Conductors2Product Code
- BZWStethoscope, Esophageal1Product Code
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)2Product Code
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)2Product Code
- CBTArterial Blood Sampling Kit1Product Code
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling2Product Code
- CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling2Product Code
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling2Product Code
- CCIAnalyzer, Gas, Nitrogen, Gaseous-Phase2Product Code
- CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase2Product Code
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase2Product Code
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase2Product Code
- CCMPlethysmograph, Pressure2Product Code
- JEDAnalyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling3Product Code
- JEFAnalyzer, Gas, Neon, Gaseous-Phase2Product Code
- JEGAnalyzer, Gas, Argon, Gaseous-Phase2Product Code
- JEHPlethysmograph, Volume2Product Code
- JFEValve, Switching (Ploss)1Product Code
- KGKGas, Collecting Vessel1Product Code
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- OFZBlood Specimen Collection Kit (Excludes Hiv Testing)1Product Code
- PNVImpedance Measuring Device Utilizing Oscillation Techniques2Product Code
- OGKOrotracheal Intubation Guide Kit2Product Code
- PHZAbnormal Breath Sound Device2Product Code
- QEBVentilatory Electrical Impedance Tomograph2Product Code
- 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
- 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
IQSense Flow Sensor Mouthpiece
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150515
- 510(k) Type
- Traditional
- Applicant
- Sdi Diagnostics, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/12/2016
- Days to Decision
- 316 days
- Submission Type
- Statement