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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 K904935
Device Name RESPIRONICS' DIGITAL MANOMETER
Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville,  PA  15668
Contact eugene n scarberry
Regulation Number868.2600
Classification Product Code
CAP  
Date Received11/01/1990
Decision Date 04/03/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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