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

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..

Clearance details

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

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