EMS300, EMS400, EMS8000— 510(k) K912642

Name: FDA 510(k) clearance K912642
Creator: U.S. Food and Drug Administration
Published: 1991-12-09

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K912642 for EMS300, EMS400, EMS8000, Substantially Equivalent on 1991-12-09. Applicant: Skylark Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Skylark Device Co., Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1991-06-14
Decision date: 1991-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, Taiwan, R.O.C., TW

Download summary PDF View on FDA.gov ↗

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