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FDA 510(k)

MYOTRON

K-Number: K761350 · 1977-03-15

ApplicantSomatronics, Inc.
Decision Date1977-03-15
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MYOTRON is the device name listed in this FDA 510(k) record. The listed applicant is Somatronics, Inc.. It received FDA 510(k) clearance on 1977-03-15 under 510(k) number K761350. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOTRON?

MYOTRON is a medical device that received FDA 510(k) clearance on 1977-03-15. The listed applicant is Somatronics, Inc.. The 510(k) number is K761350.

When did MYOTRON receive FDA 510(k) clearance?

MYOTRON received FDA 510(k) clearance on 1977-03-15, under 510(k) number K761350.

Who is the listed applicant for MYOTRON?

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

What is the FDA product code for MYOTRON?

The FDA product code for MYOTRON is HCC.

Related Clinical Trials

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Other records listing Somatronics, Inc. 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.

K782127STIMULATOR, ELECTRICAL NERVE

Related Devices (Code: HCC)

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

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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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