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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 K143148
Device Name Disposable Pressure Manometer (DPM)
Westmed, Inc.
5580 S. Nogales Hwy.
Tucson,  AZ  85706
Applicant Contact DIANA UPP
Westmed, Inc.
5580 S. Nogales Hwy.
Tucson,  AZ  85706
Correspondent Contact PAUL DRYDEN
Regulation Number868.2600
Classification Product Code
Date Received11/03/2014
Decision Date 08/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No