SD-956 ULTRASOUND THERAPY— 510(k) K981449

Name: FDA 510(k) clearance K981449
Creator: U.S. Food and Drug Administration
Published: 1998-12-11

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K981449 for SD-956 ULTRASOUND THERAPY, Substantially Equivalent on 1998-12-11. Applicant: Skylark Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Skylark Device Co., Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 1998-04-22
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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