SPECTRAL OCT/SLO


Device Classification Name

tomography, optical coherence

510(k) Number K080460
Device Name SPECTRAL OCT/SLO
Applicant
OPKO HEALTH, INC.
4400 biscayne blvd.
miami, 
FL 
33137

Applicant Contact jane hsiao
Correspondent
OPKO HEALTH, INC.
4400 biscayne blvd.
miami, 
FL 
33137

Correspodent Contact jane hsiao
Regulation Number 886.1570
Classification Product Code
OBO  
Date Received 02/20/2008
Decision Date 11/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No