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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K802955
Device Name MONITOR, AIRWAY PRESSURE
Applicant
Novametrix Medical Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Novametrix Medical Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.2600
Classification Product Code
CAP  
Date Received11/20/1980
Decision Date 12/19/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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