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FDA 510(k)

Monarch Airway Clearance System

K-Number: K163378 · 2017-03-17

ApplicantHill-Rom Services Pte, Ltd.
Decision Date2017-03-17
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Monarch Airway Clearance System is a medical device manufactured by Hill-Rom Services Pte, Ltd.. It received FDA 510(k) clearance on 2017-03-17 under approval number K163378. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monarch Airway Clearance System?

Monarch Airway Clearance System is a medical device that received FDA 510(k) clearance on 2017-03-17. It is manufactured by Hill-Rom Services Pte, Ltd.. The 510(k) number is K163378.

When was Monarch Airway Clearance System approved by the FDA?

Monarch Airway Clearance System received FDA 510(k) clearance on 2017-03-17, under approval number K163378.

What company makes Monarch Airway Clearance System?

Monarch Airway Clearance System is manufactured by Hill-Rom Services Pte, Ltd..

What is the FDA product code for Monarch Airway Clearance System?

The FDA product code for Monarch Airway Clearance System is BYI.

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Other Devices by Hill-Rom Services Pte, Ltd.

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Related Devices (Code: BYI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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