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FDA 510(k)

MYOTRAC2D/CS

K-Number: K925681 · 1995-09-29

ApplicantThought Technology , Ltd.
Decision Date1995-09-29
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MYOTRAC2D/CS is the device name listed in this FDA 510(k) record. The listed applicant is Thought Technology , Ltd.. It received FDA 510(k) clearance on 1995-09-29 under 510(k) number K925681. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOTRAC2D/CS?

MYOTRAC2D/CS is a medical device that received FDA 510(k) clearance on 1995-09-29. The listed applicant is Thought Technology , Ltd.. The 510(k) number is K925681.

When did MYOTRAC2D/CS receive FDA 510(k) clearance?

MYOTRAC2D/CS received FDA 510(k) clearance on 1995-09-29, under 510(k) number K925681.

Who is the listed applicant for MYOTRAC2D/CS?

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

What is the FDA product code for MYOTRAC2D/CS?

The FDA product code for MYOTRAC2D/CS is HIR.

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Other records listing Thought Technology , Ltd. as applicant

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K213197MyOnyx SystemK201014MyOnyx SystemK053434MYOTRAC INFINITI ELECTRICAL STIMULATORK053266MYOTRAC INFINITIK935213INCONTROLK932149THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE

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Related Devices (Code: HIR)

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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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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