510(k) K142482

The Vest Airway Clearance System by Hill-Rom Services Private Limited — Product Code BYI

K142482 is an FDA 510(k) premarket notification submitted by Hill-Rom Services Private Limited for the device "The Vest Airway Clearance System". The FDA issued a decision of Substantially Equivalent on May 7, 2015. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2015
Date Received
September 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type