Monarch Airway Clearance System

FDA 510(k) K163378 · Hill-Rom Services Pte, Ltd.

Substantially Equivalent

510(k) numberK163378

Submission

Device name
Monarch Airway Clearance System
Applicant
Hill-Rom Services Pte, Ltd.
Singapore, SG
Received
December 1, 2016
Decision date
March 17, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BYI – Percussor, Powered-Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5665
Specialty
Anesthesiology

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Questions and answers

When was Monarch Airway Clearance System cleared by the FDA?

Monarch Airway Clearance System (K163378) received a 510(k) decision of Substantially Equivalent on March 17, 2017, 106 days after the submission was received.

What is the product code of K163378?

The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.