RTVUE CAM WITH CORNEAL POWER UPGRADE


Device Classification Name

tomography, optical coherence

510(k) Number K111505
Device Name RTVUE CAM WITH CORNEAL POWER UPGRADE
Applicant
OPTOVUE, INC.
45531 northport loop w.
fremont, 
CA 
94538

Applicant Contact john talarico
Correspondent
OPTOVUE, INC.
45531 northport loop w.
fremont, 
CA 
94538

Correspodent Contact john talarico
Regulation Number 886.1570
Classification Product Code
OBO  
Subsequent Product Code
MMQ  
Date Received 05/31/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls