Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- BXHGauge, Gas Pressure, Cylinder/Pipeline1Product Code
- BXMStimulator, Nerve, Ac-Powered2Product Code
- BXNStimulator, Nerve, Battery-Powered2Product Code
- BXOTransducer, Gas Pressure1Product Code
- BXPTransducer, Gas Flow1Product Code
- BXXCalibrator, Pressure, Gas1Product Code
- BXYFlowmeter, Calibration, Gas1Product Code
- BYMTube, Thorpe, Uncompensated1Product Code
- BYRTransducer, Gas Pressure, Differential1Product Code
- BZQMonitor, Breathing Frequency2Product Code
- CANRegulator, Pressure, Gas Cylinder1Product Code
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)2Product Code
- K201666SINGLE USE MANOMETER2Cleared 510(K)
- K182292VORTRAN APM-Plus2Cleared 510(K)
- K180510NS 120P-TRS Airway Pressure Gauge2Cleared 510(K)
- K172284NAPA LP-15 Airway Pressure Monitor2Cleared 510(K)
- K153733VORTRAN Manometer2Cleared 510(K)
- K143148Disposable Pressure Manometer (DPM)2Cleared 510(K)
- K140370DISPOSABLE PRESSURE MANOMETER2Cleared 510(K)
- K122627GIO DIGITAL PRESSURE GUAGES2Cleared 510(K)
- K122077MANOMETER2Cleared 510(K)
- K120118VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER2Cleared 510(K)
- K103639VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC2Cleared 510(K)
- K110119PRESSURE MANOMETER2Cleared 510(K)
- K102377VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 02Cleared 510(K)
- K081778NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS2Cleared 510(K)
- K050309PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-50002Cleared 510(K)
- K040991AMBU DISPOSABLE PRESSURE MANOMETER2Cleared 510(K)
- K022402DISPOSABLE PRESSURE MANOMETER2Cleared 510(K)
- K003497DISPOSABLE PRESSURE MONITOR2Cleared 510(K)
- K000959CRITERION 60 OR PM 602Cleared 510(K)
- K992101CRITERION 40 OR PM 402Cleared 510(K)
- K973347TSX PRM PULMONARY RESUSCITATION MONITOR2Cleared 510(K)
- K9613181ST RESPONSE DISPOSABLE MANOMETER2Cleared 510(K)
- K954486MERCURY AIRWAY PRESSURE MANOMETER2Cleared 510(K)
- K936009AMS 3000M2Cleared 510(K)
- K943146PORTA-RESP MONITOR2Cleared 510(K)
- K940375MICRO MPM2Cleared 510(K)
- K931394CM5000R REMOTE INDICATOR2Cleared 510(K)
- K931287CM7000 REMOTE INDICATOR2Cleared 510(K)
- K925673AIRWAY PRESSURE MONITOR CM 5000 NGAN2Cleared 510(K)
- K921978BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE2Cleared 510(K)
- K904935RESPIRONICS' DIGITAL MANOMETER2Cleared 510(K)
- N83074NON-ABSORBABLE BLACK SILK SUTURE2PMA Approval
- K902381PENLON BREATHING SYSTEM PRESSURE MONITOR2Cleared 510(K)
- K902276RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)2Cleared 510(K)
- K896136INFANT C.P.A.P. MONITOR2Cleared 510(K)
- K895747VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR2Cleared 510(K)
- K894361LIFECARE PRESSURE ALARM CAT. NO. 34-0102Cleared 510(K)
- K894689PENLON IDP PRESSURE FAILURE ALARM2Cleared 510(K)
- K892942BREATH TRACKER2Cleared 510(K)
- K890010CM 7000MR2Cleared 510(K)
- K873953CM 5000R REMOTE AIRWAY PRESSURE2Cleared 510(K)
- K871336M-1 PRESSURE MONITOR2Cleared 510(K)
- K871139M-10 VENTILATION MONITOR2Cleared 510(K)
- K871083CM 5000 MONITOR AIRWAY PRESSURE2Cleared 510(K)
- K864536OHMEDA 5500 AIRWAY PRESSURE MONITOR2Cleared 510(K)
- N83074NON-ABSORBABLE BLACK SILK SUTURE2PMA Approval
- K861720MODIFIED BAROMED BREATHING PRESSURE MONITOR2Cleared 510(K)
- K861330SECHRIST AIRWAY PRESSURE MONITOR MODEL 6002Cleared 510(K)
- K854934VENTILATOR PRESSURE ALARM MODEL VPA-1002Cleared 510(K)
- K852826AN PRESSURE MONITOR2Cleared 510(K)
- K852824PMA PRESSURE MONITOR2Cleared 510(K)
- K851905LPA-2 REMOTE ALARM2Cleared 510(K)
- N83074NON-ABSORBABLE BLACK SILK SUTURE2PMA Approval
- K840420AIRWAY PRESSURE MONITOR2Cleared 510(K)
- K840279DRAGER BAROMED2Cleared 510(K)
- K832271EMERSON MODEL 3MV-AP AND 3V-AP PRESS-2Cleared 510(K)
- K821649MONAGHAN'S PRESSURE ALARM2Cleared 510(K)
- K821667SINGLE USE NON-CONDUCTIVE CIRC. DISCON2Cleared 510(K)
- K820720RESPIRATOR MONITOR2Cleared 510(K)
- K820353MONITRON MODEL JL-72Cleared 510(K)
- K812960EAST VENTILARM PRESSURE MONITOR ALARM S.2Cleared 510(K)
- K812041VENTI-MONITOR MODEL 1012Cleared 510(K)
- K812140BIRD MEAN AIRWAY PRESSURE MONITOR2Cleared 510(K)
- K810753AIRWAY PRESSURE MONITOR2Cleared 510(K)
- K810648SECHRIST AIRWAY PRESSURE MONITOR #4002Cleared 510(K)
- K810547BLSI VENTILATION MONITOR2Cleared 510(K)
- K810255MEAN PRESSURE MONITOR2Cleared 510(K)
- K802955MONITOR, AIRWAY PRESSURE2Cleared 510(K)
- K802054TRAVENOL ULTRASONIC NEBULIZER CUPS2Cleared 510(K)
- K8025653MP-7 SCANNER RESPIRATORY MONITOR2Cleared 510(K)
- K802090DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC2Cleared 510(K)
- K801254PENLON I.D.P. PRESSSURE FAILURE ALARM2Cleared 510(K)
- K792515RESPIRATOR DISCONNECT ALARM2Cleared 510(K)
- K792516RESPIRATOR DISCONNECT ALARM CR 2012Cleared 510(K)
- K791561RESPIRATOR DISCONNECT ALARM VA-1002Cleared 510(K)
- K791527RESPIRATOR DISCONNECT ALARM CR2012Cleared 510(K)
- K790370BUNN MODEL #40 LOW PRESSURE ALARM2Cleared 510(K)
- K782174PRESSURE ALARM2Cleared 510(K)
- K781714PNEUMOGARD MODEL 12302Cleared 510(K)
- K781697PRESSURE, LOW/HIGH MODEL C10702Cleared 510(K)
- K780863MODEL 65 HIGH & LOW PRESSURE ALARM2Cleared 510(K)
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated1Product Code
- CBAMonitor, Air Embolism, Ultrasonic2Product Code
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge1Product Code
- ECXCylinder, Compressed Gas, And Valve1Product Code
- FLSMonitor, Apnea, Facility Use2Product Code
- JAXPneumotachometer2Product Code
- JEZMonitor, Lung Water Measurement3Product Code
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia2Product Code
- KOIStimulator, Nerve, Peripheral, Electric2Product Code
- LKDMonitor, Carbon-Dioxide, Cutaneous2Product Code
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia2Product Code
- MNRVentilatory Effort Recorder2Product Code
- MRPAnalyzer, Nitric Oxide2Product Code
- MRQAnalyzer, Nitrogen Dioxide2Product Code
- NPFMonitor, Apnea, Home Use2Product Code
- PRKDevice Indicating An Exhalation Event2Product Code
- PUGAnalyzer, Nitrogen Dioxide, Exempt2Product Code
- PXEPressure Monitoring (Air/Gas) Kit1Product Code
- 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 TRACKER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K892942
- 510(k) Type
- Traditional
- Applicant
- CORE-M, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/23/1989
- Days to Decision
- 63 days