BIO TENS 601, 606 AND 608 (3000)— 510(k) K912178

Name: FDA 510(k) clearance K912178
Creator: U.S. Food and Drug Administration
Published: 1991-10-25

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K912178 for BIO TENS 601, 606 AND 608 (3000), Substantially Equivalent on 1991-10-25. 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: 1991-05-16
Decision date: 1991-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, Taiwan, R.O.C., TW

Download summary PDF View on FDA.gov ↗

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