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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name percussor, powered-electric
510(k) Number K142482
Device Name The Vest Airway Clearance System
Hill-Rom Services Private Limited
1 Yishum Avenue 7
Singapore,  SG 768923
Applicant Contact Christina Miracle
ProMedic, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number868.5665
Classification Product Code
Date Received09/04/2014
Decision Date 05/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No