MONITOR, AIRWAY PRESSURE

Monitor, Airway Pressure (includes Gauge And/or Alarm)

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Monitor, Airway Pressure.

Pre-market Notification Details

Device IDK802955
510k NumberK802955
Device Name:MONITOR, AIRWAY PRESSURE
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCAP  
CFR Regulation Number868.2600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-20
Decision Date1980-12-19

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