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FDA 510(k)

SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT

K-Number: K850640 · 1985-05-14

ApplicantFluidotherapy Corp.
Decision Date1985-05-14
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Fluidotherapy Corp.. It received FDA 510(k) clearance on 1985-05-14 under 510(k) number K850640. 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 SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT?

SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT is a medical device that received FDA 510(k) clearance on 1985-05-14. The listed applicant is Fluidotherapy Corp.. The 510(k) number is K850640.

When did SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT receive FDA 510(k) clearance?

SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT received FDA 510(k) clearance on 1985-05-14, under 510(k) number K850640.

Who is the listed applicant for SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT?

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

What is the FDA product code for SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT?

The FDA product code for SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT is IMI.

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 Fluidotherapy 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.

K850573CURAMED 402K832122ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED

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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