SD-602 SD MODE 11, SD-603 SD MOD 111— 510(k) K925729

Name: FDA 510(k) clearance K925729
Creator: U.S. Food and Drug Administration
Published: 1993-01-22

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K925729 for SD-602 SD MODE 11, SD-603 SD MOD 111, Substantially Equivalent on 1993-01-22. 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: 1992-11-13
Decision date: 1993-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, Taiwan, R.O.C., TW

Download summary PDF View on FDA.gov ↗

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