ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE


Device Classification Name

colposcope (and colpomicroscope)

510(k) Number K110147
Device Name ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
Applicant
STI MEDICAL SYSTEMS, LLC
4275 executive square,
suite 825
la jolla, 
CA 
92037

Applicant Contact rolf wolters
Correspondent
STI MEDICAL SYSTEMS, LLC
4275 executive square,
suite 825
la jolla, 
CA 
92037

Correspodent Contact rolf wolters
Regulation Number 884.1630
Classification Product Code
HEX  
Date Received 01/18/2011
Decision Date 04/08/2011
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