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
- BZHMeter, Peak Flow, Spirometry2Product Code
- K230423Electronic Peak Flow Meter2Cleared 510(K)
- K222810TD-7301 Peak Flow meter2Cleared 510(K)
- K203196Peak flow meter2Cleared 510(K)
- K200832Safey Peak Flow Meter2Cleared 510(K)
- K193311Aluna2Cleared 510(K)
- K191239Smart Peak Flow Meter2Cleared 510(K)
- K180487Peak.me2Cleared 510(K)
- K181666Smart One2Cleared 510(K)
- K172804Besmed Peak Flow Meter2Cleared 510(K)
- K170281MSA100BT Peak Flow Meter2Cleared 510(K)
- K152276Wing Smart FEVI and Peak Flow Meter2Cleared 510(K)
- K133975MSA100 PEAK FLOW METER2Cleared 510(K)
- K123945STRIVE DUAL ZONE PEAK FLOW METER2Cleared 510(K)
- K101380RXPEAKFLOW2Cleared 510(K)
- K092335PEAK EXPIRATORY FLOW METER, KN-97102Cleared 510(K)
- K091412CLEAN PEAK FLOW METER2Cleared 510(K)
- K082899DYNAMIPEAK PEAK FLOW METER2Cleared 510(K)
- K053156MINI-WRIGHT DIGITAL, MODEL 31200012Cleared 510(K)
- K050853PMP4 SPIROPRO2Cleared 510(K)
- K040723MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)2Cleared 510(K)
- K031024MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-1002Cleared 510(K)
- K030586MICROPEAK2Cleared 510(K)
- K031514MODIFICATION TO TRUPEAK PEAK FLOW METER2Cleared 510(K)
- K022124GALEMED PEAK FLOW METER, MODELS 3751/37522Cleared 510(K)
- K023097TRUEZONE PEAK FLOW METER2Cleared 510(K)
- K013489KP + LFM2Cleared 510(K)
- K010009KOKO PEAK KP; KOKO PEAK KP+2Cleared 510(K)
- K980951ONEFLOW2Cleared 510(K)
- K991412VITALOGRAPH MICRO2Cleared 510(K)
- K992618RESPALERT2Cleared 510(K)
- K991212MODIFICATION TO TRUZONE PEAK FLOW METER2Cleared 510(K)
- K982334AIRZONE PEAK FLOWMETER2Cleared 510(K)
- K982995ACCUTRAX, MODEL EPF8402Cleared 510(K)
- K982676AIRWATCH II ZONE2Cleared 510(K)
- K982675AIRWATCH II ZONELESS2Cleared 510(K)
- K980550WHISTLE WATCH2Cleared 510(K)
- K980960IN-CHECK INSPIRATORY FLOWMETER2Cleared 510(K)
- K980443PEAK FLOW METER MINIMAX2Cleared 510(K)
- K970507PEAK FLOW METER2Cleared 510(K)
- K961779MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER2Cleared 510(K)
- K964130AEROGEAR ASTHMA ACTION KIT2Cleared 510(K)
- K962074VM PLUS PEAK FLOWMETER2Cleared 510(K)
- K963089TRUZONE PEAK FLOW METER2Cleared 510(K)
- K963095TRUPEAK PEAK FLOW METER2Cleared 510(K)
- K962924PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM2Cleared 510(K)
- K962929PERSONAL BEST II2Cleared 510(K)
- K953411BREATH-TAKER BREATH-ALERT2Cleared 510(K)
- K952909AUTOZONE2Cleared 510(K)
- K952713MINI WRIGHT LR AFS2Cleared 510(K)
- K955234TRUPEAK PEAK FLOW METER2Cleared 510(K)
- K955262TRUZONE PEAK FLOW METER2Cleared 510(K)
- K954277ASTECH PEAK FLOW METER2Cleared 510(K)
- K943678ELECTRONIC FLOW METER2Cleared 510(K)
- K953458RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN2Cleared 510(K)
- K934795CARD GUARD2Cleared 510(K)
- K936110ASPIRE2Cleared 510(K)
- K941226AIRWATCH MONITOR2Cleared 510(K)
- K940835PEAKLOG AND DISPLAY SOFTWARE2Cleared 510(K)
- K940836PEAKLOG AND DISPLAY SOFTWARE2Cleared 510(K)
- K924322FLOW=MED2Cleared 510(K)
- K934502FLOW SPIROMETER2Cleared 510(K)
- K933889PERSONAL BEST LOW RANGE2Cleared 510(K)
- K926307PEAK FLOW METER2Cleared 510(K)
- K924343WRIGHT POCKET PEAK FLOW METER2Cleared 510(K)
- K914126VMX MINI-LOG FLOWMETER2Cleared 510(K)
- K920390THE PEAK2Cleared 510(K)
- K915060ASTECH HOME PEAK FLOW METER2Cleared 510(K)
- K912866PEAK EXPIRATORY FLOW METER2Cleared 510(K)
- K915059PEAK FLOW MONITOR2Cleared 510(K)
- K902292MODIFIED ASSESS(R) PEAK FLOW METER2Cleared 510(K)
- K896953MODIFIED ASSESS(R) PEAK FLOW METER2Cleared 510(K)
- K853922PLOTTER FOR AS-5002Cleared 510(K)
- K851265PEAK FLOWMETERS FOR SPIROMETRY2Cleared 510(K)
- K813414PEAK FLOW MONITOR2Cleared 510(K)
- K781922PULMONARY MONITOR2Cleared 510(K)
- K781224METER, FLOW, PEAK2Cleared 510(K)
- K770580PEAK FLOW METER2Cleared 510(K)
- 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 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
BREATH-TAKER BREATH-ALERT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K953411
- 510(k) Type
- Traditional
- Applicant
- ROXON - UNIVERSAL MEDICAL LTD.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/13/1996
- Days to Decision
- 329 days
- Submission Type
- Statement