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FDA 510(k)

PULSARII, HIGH VOLT. GALVANIC MUSC. STIM

K-Number: K810064 · 1981-01-26

ApplicantBomed Medical Mfr., Ltd.
Decision Date1981-01-26
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PULSARII, HIGH VOLT. GALVANIC MUSC. STIM is the device name listed in this FDA 510(k) record. The listed applicant is Bomed Medical Mfr., Ltd.. It received FDA 510(k) clearance on 1981-01-26 under 510(k) number K810064. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSARII, HIGH VOLT. GALVANIC MUSC. STIM?

PULSARII, HIGH VOLT. GALVANIC MUSC. STIM is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Bomed Medical Mfr., Ltd.. The 510(k) number is K810064.

When did PULSARII, HIGH VOLT. GALVANIC MUSC. STIM receive FDA 510(k) clearance?

PULSARII, HIGH VOLT. GALVANIC MUSC. STIM received FDA 510(k) clearance on 1981-01-26, under 510(k) number K810064.

Who is the listed applicant for PULSARII, HIGH VOLT. GALVANIC MUSC. STIM?

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

What is the FDA product code for PULSARII, HIGH VOLT. GALVANIC MUSC. STIM?

The FDA product code for PULSARII, HIGH VOLT. GALVANIC MUSC. STIM is IPF.

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Other records listing Bomed Medical Mfr., Ltd. as applicant

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Related Devices (Code: IPF)

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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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