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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 the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom Services Pte, Ltd.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) 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. The listed applicant is Hill-Rom Services Pte, Ltd.. The 510(k) number is K163378.

When did Monarch Airway Clearance System receive FDA 510(k) clearance?

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

Who is the listed applicant for Monarch Airway Clearance System?

The FDA 510(k) record lists Hill-Rom Services Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Hill-Rom Services Pte, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BYI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalK250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.

Official Source

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

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