AIRWAY PRESSURE MONITOR

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

IMPACT INSTRUMENTATION, INC.

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

Pre-market Notification Details

Device IDK810753
510k NumberK810753
Device Name:AIRWAY PRESSURE MONITOR
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant IMPACT INSTRUMENTATION, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAP  
CFR Regulation Number868.2600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-20
Decision Date1981-03-31

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