SD-605 SD II PROGRAM— 510(k) K923935

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K923935 for SD-605 SD II PROGRAM, Substantially Equivalent on 1992-10-15. 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: 1992-08-05
Decision date: 1992-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, Taiwan, R.O.C., TW

Download summary PDF View on FDA.gov ↗

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