GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.— 510(k) K091833

Name: FDA 510(k) clearance K091833
Creator: U.S. Food and Drug Administration
Published: 2009-10-16

Substantially Equivalent

Gemore Technology Co, Ltd.

FDA 510(k) clearance K091833 for GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE., Substantially Equivalent on 2009-10-16. Applicant: Gemore Technology Co, Ltd.. Device class: 2.

Clearance details

Applicant: Gemore Technology Co, Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2009-06-22
Decision date: 2009-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tan Shui, New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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