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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 K781714
Device Name PNEUMOGARD MODEL 1230
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
Regulation Number868.2600
Classification Product Code
CAP  
Date Received10/06/1978
Decision Date 11/27/1978
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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