GEM-STIM COMBO STIMULATOR— 510(k) K122948

Name: FDA 510(k) clearance K122948
Creator: U.S. Food and Drug Administration
Published: 2012-12-21

Substantially Equivalent

Gemore Technology Co, Ltd.

FDA 510(k) clearance K122948 for GEM-STIM COMBO STIMULATOR, Substantially Equivalent on 2012-12-21. 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: 2012-09-24
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Tan Shui, New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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