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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 K233441
Device Name The Vest APX System (PVAPX1)
Applicant
Baxter Healthcare Corportation
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Applicant Contact Steven Co
Correspondent
Baxter Healthcare Corportation
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Correspondent Contact Steven Co
Regulation Number868.5665
Classification Product Code
BYI  
Date Received10/18/2023
Decision Date 03/22/2024
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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