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FDA 510(k)

LibAirty Airway Clearance System

K-Number: K242063 · 2024-12-19

ApplicantSynchrony Medical , Ltd.
Decision Date2024-12-19
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LibAirty Airway Clearance System is the device name listed in this FDA 510(k) record. The listed applicant is Synchrony Medical , Ltd.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242063. 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 LibAirty Airway Clearance System?

LibAirty Airway Clearance System is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Synchrony Medical , Ltd.. The 510(k) number is K242063.

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

LibAirty Airway Clearance System received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242063.

Who is the listed applicant for LibAirty Airway Clearance System?

The FDA 510(k) record lists Synchrony Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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.

NCT07135284Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS)RECRUITING

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, LLCK240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc.

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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