SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)— 510(k) K963729

Name: FDA 510(k) clearance K963729
Creator: U.S. Food and Drug Administration
Published: 1997-02-13

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K963729 for SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD), Substantially Equivalent on 1997-02-13. Applicant: Skylark Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Skylark Device Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1996-09-16
Decision date: 1997-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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