GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000


Device Classification Name

colposcope (and colpomicroscope)

510(k) Number K021153
Device Name GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
Original Applicant
GOLDWAY US, INC.
12 south first street,
suite 1205
san jose, 
CA 
95113

Original Contact y. justin chen
Regulation Number 884.1630
Classification Product Code
HEX  
Date Received 04/10/2002
Decision Date 02/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No