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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 K024309
Device Name THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
Applicant
Advanced Respiratory
1020 W. County Rd. F
St. Paul,  MN  55126
Applicant Contact ERIC J LARSON
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact N.E. DEVINE
Regulation Number868.5665
Classification Product Code
BYI  
Date Received12/24/2002
Decision Date 02/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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