510(k) K173603

Monarch Airway Clearance System by Hill-Rom Holdings, Inc. — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2018
Date Received
November 21, 2017
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