GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000— 510(k) K021153

Name: FDA 510(k) clearance K021153
Creator: U.S. Food and Drug Administration
Published: 2003-02-10

Substantially Equivalent

Goldway Us, Inc.

FDA 510(k) clearance K021153 for GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000, Substantially Equivalent on 2003-02-10. Applicant: Goldway Us, Inc.. Device class: 2.

Clearance details

Applicant: Goldway Us, Inc.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2002-04-10
Decision date: 2003-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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