IVUE WITH NORMATIVE DATABASE


Device Classification Name

ophthalmoscope, ac-powered

510(k) Number K121739
Device Name IVUE WITH NORMATIVE DATABASE
Applicant
OPTOVUE, INC.
45531 northport loop w
fremont, 
CA 
94538

Applicant Contact azimun jamal
Correspondent
OPTOVUE, INC.
45531 northport loop w
fremont, 
CA 
94538

Correspodent Contact azimun jamal
Regulation Number 886.1570
Classification Product Code
HLI  
Date Received 06/13/2012
Decision Date 01/18/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Clinical Trials NCT01459731
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls