TNS MK I STIMULATOR— 510(k) K812612

Substantially Equivalent

Edu Kit , Ltd.

FDA 510(k) clearance K812612 for TNS MK I STIMULATOR, Substantially Equivalent on 1982-02-18. Applicant: Edu Kit , Ltd.. Device class: 2.

Clearance details

Applicant: Edu Kit , Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1981-09-15
Decision date: 1982-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.