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FDA 510(k)

TNS MK I STIMULATOR

K-Number: K812612 · 1982-02-18

Decision Date1982-02-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TNS MK I STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Edu Kit , Ltd.. It received FDA 510(k) clearance on 1982-02-18 under 510(k) number K812612. 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 TNS MK I STIMULATOR?

TNS MK I STIMULATOR is a medical device that received FDA 510(k) clearance on 1982-02-18. The listed applicant is Edu Kit , Ltd.. The 510(k) number is K812612.

When did TNS MK I STIMULATOR receive FDA 510(k) clearance?

TNS MK I STIMULATOR received FDA 510(k) clearance on 1982-02-18, under 510(k) number K812612.

Who is the listed applicant for TNS MK I STIMULATOR?

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

What is the FDA product code for TNS MK I STIMULATOR?

The FDA product code for TNS MK I STIMULATOR is GZJ.

Related Clinical Trials

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.

Related Devices (Code: GZJ)

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.

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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