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FDA 510(k)

TRANSCUTANEOUS ELECTRICAL NERVE

K-Number: K811095 · 1981-07-01

ApplicantAcutec Corporation, Inc.
Decision Date1981-07-01
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS ELECTRICAL NERVE is the device name listed in this FDA 510(k) record. The listed applicant is Acutec Corporation, Inc.. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811095. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSCUTANEOUS ELECTRICAL NERVE?

TRANSCUTANEOUS ELECTRICAL NERVE is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Acutec Corporation, Inc.. The 510(k) number is K811095.

When did TRANSCUTANEOUS ELECTRICAL NERVE receive FDA 510(k) clearance?

TRANSCUTANEOUS ELECTRICAL NERVE received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811095.

Who is the listed applicant for TRANSCUTANEOUS ELECTRICAL NERVE?

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

What is the FDA product code for TRANSCUTANEOUS ELECTRICAL NERVE?

The FDA product code for TRANSCUTANEOUS ELECTRICAL NERVE is GZJ.

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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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