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FDA 510(k)

THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104

K-Number: K024309 · 2003-02-21

ApplicantAdvanced Respiratory
Decision Date2003-02-21
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Respiratory. It received FDA 510(k) clearance on 2003-02-21 under 510(k) number K024309. 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 THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104?

THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 is a medical device that received FDA 510(k) clearance on 2003-02-21. The listed applicant is Advanced Respiratory. The 510(k) number is K024309.

When did THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 receive FDA 510(k) clearance?

THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 received FDA 510(k) clearance on 2003-02-21, under 510(k) number K024309.

Who is the listed applicant for THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104?

The FDA 510(k) record lists Advanced Respiratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104?

The FDA product code for THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 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.

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Other records listing Advanced Respiratory 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.

K012928ABI VEST AIRWAY CLEARANCE SYSTEM

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

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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