IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II— 510(k) K946337

Name: FDA 510(k) clearance K946337
Creator: U.S. Food and Drug Administration
Published: 1995-12-20

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K946337 for IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II, Substantially Equivalent on 1995-12-20. Applicant: Skylark Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Skylark Device Co., Ltd.
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 1994-12-29
Decision date: 1995-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taiwan, R.O.C., TW

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