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510(k) K173603

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

K173603 is an FDA 510(k) premarket notification submitted by Hill-Rom Holdings, Inc. for the device "Monarch Airway Clearance System". The FDA issued a decision of Substantially Equivalent on October 24, 2018. 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
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

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FDA data resources