GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)— 510(k) K032994

Name: FDA 510(k) clearance K032994
Creator: U.S. Food and Drug Administration
Published: 2003-12-16

Substantially Equivalent

Gemore Technology Co, Ltd.

FDA 510(k) clearance K032994 for GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING), Substantially Equivalent on 2003-12-16. Applicant: Gemore Technology Co, Ltd.. Device class: 2.

Clearance details

Applicant: Gemore Technology Co, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2003-09-25
Decision date: 2003-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tan Shui, Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

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