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FDA 510(k)

MYOTRACK, MODEL HH 515

K-Number: K904025 · 1991-03-01

ApplicantMyotrack Co.
Decision Date1991-03-01
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MYOTRACK, MODEL HH 515 is the device name listed in this FDA 510(k) record. The listed applicant is Myotrack Co.. It received FDA 510(k) clearance on 1991-03-01 under 510(k) number K904025. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOTRACK, MODEL HH 515?

MYOTRACK, MODEL HH 515 is a medical device that received FDA 510(k) clearance on 1991-03-01. The listed applicant is Myotrack Co.. The 510(k) number is K904025.

When did MYOTRACK, MODEL HH 515 receive FDA 510(k) clearance?

MYOTRACK, MODEL HH 515 received FDA 510(k) clearance on 1991-03-01, under 510(k) number K904025.

Who is the listed applicant for MYOTRACK, MODEL HH 515?

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

What is the FDA product code for MYOTRACK, MODEL HH 515?

The FDA product code for MYOTRACK, MODEL HH 515 is BXN.

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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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