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FDA 510(k)

DYNASOUND 801

K-Number: K811159 · 1981-05-27

ApplicantDynawave, Corp.
Decision Date1981-05-27
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DYNASOUND 801 is the device name listed in this FDA 510(k) record. The listed applicant is Dynawave, Corp.. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K811159. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNASOUND 801?

DYNASOUND 801 is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Dynawave, Corp.. The 510(k) number is K811159.

When did DYNASOUND 801 receive FDA 510(k) clearance?

DYNASOUND 801 received FDA 510(k) clearance on 1981-05-27, under 510(k) number K811159.

Who is the listed applicant for DYNASOUND 801?

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

What is the FDA product code for DYNASOUND 801?

The FDA product code for DYNASOUND 801 is IMI.

Related Clinical Trials

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Other records listing Dynawave, Corp. 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.

K934287DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATORK791976DYNASOUND 601

Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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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