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FDA 510(k)

THAIRAPY VEST SYSTEM

K-Number: K965192 · 1997-06-24

ApplicantAmerican Biosystems, Inc.
Decision Date1997-06-24
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THAIRAPY VEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Biosystems, Inc.. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K965192. 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 THAIRAPY VEST SYSTEM?

THAIRAPY VEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is American Biosystems, Inc.. The 510(k) number is K965192.

When did THAIRAPY VEST SYSTEM receive FDA 510(k) clearance?

THAIRAPY VEST SYSTEM received FDA 510(k) clearance on 1997-06-24, under 510(k) number K965192.

Who is the listed applicant for THAIRAPY VEST SYSTEM?

The FDA 510(k) record lists American Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THAIRAPY VEST SYSTEM?

The FDA product code for THAIRAPY VEST SYSTEM is BYI.

Related Clinical Trials

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Other records listing American Biosystems, Inc. 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.

K993629ABI VEST AIRWAY CLEARANCE SYSTEMK936121THAIRAPY SYSTEMK884098THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101

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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