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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 K140370
Device Name DISPOSABLE PRESSURE MANOMETER
Applicant
Besmed Health Business Corp
#5, Ln.116, Wu-Kong 2nd Rd.
New Taipei City, Wu-Ku District,  TW TW
Applicant Contact PAUL DRYDEN
Correspondent
Besmed Health Business Corp
#5, Ln.116, Wu-Kong 2nd Rd.
New Taipei City, Wu-Ku District,  TW TW
Correspondent Contact PAUL DRYDEN
Regulation Number868.2600
Classification Product Code
CAP  
Date Received02/14/2014
Decision Date 06/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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