RESPIRATOR DISCONNECT ALARM

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

INTERSECT MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Intersect Medical Products, Inc. with the FDA for Respirator Disconnect Alarm.

Pre-market Notification Details

Device IDK792515
510k NumberK792515
Device Name:RESPIRATOR DISCONNECT ALARM
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant INTERSECT MEDICAL PRODUCTS, 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 Received1979-12-05
Decision Date1980-01-09

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