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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 K122077
Device Name MANOMETER
Applicant
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool,  NY  13088
Applicant Contact michael zalewski
Correspondent
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool,  NY  13088
Correspodent Contact michael zalewski
Regulation Number868.2600
Classification Product Code
CAP  
Date Received07/16/2012
Decision Date 01/10/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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