BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)— 510(k) K934051

Name: FDA 510(k) clearance K934051
Creator: U.S. Food and Drug Administration
Published: 1994-07-11

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K934051 for BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD), Substantially Equivalent on 1994-07-11. 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: 1993-08-19
Decision date: 1994-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taiwan, R.O.C., TW

Download summary PDF View on FDA.gov ↗

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