TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR— 510(k) K802678

Name: FDA 510(k) clearance K802678
Creator: U.S. Food and Drug Administration
Published: 1980-12-10

Substantially Equivalent

General Medical Industries, Inc.

FDA 510(k) clearance K802678 for TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR, Substantially Equivalent on 1980-12-10. Applicant: General Medical Industries, Inc.. Device class: 2.

Clearance details

Applicant: General Medical Industries, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1980-10-29
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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