MEAN PRESSURE MONITOR

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

HEALTHDYNE, INC.

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

Pre-market Notification Details

Device IDK810255
510k NumberK810255
Device Name:MEAN PRESSURE MONITOR
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant HEALTHDYNE, 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 Received1981-01-30
Decision Date1981-02-12

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