CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)


Device Classification Name

biomicroscope, slit-lamp, ac-powered

510(k) Number K072861
Device Name CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
Applicant
ACHEVE TECHNOLOGY, INC.
17100 gillette ave., unit 113
irvin, 
CA 
92614

Applicant Contact jim-son chou
Correspondent
ACHEVE TECHNOLOGY, INC.
17100 gillette ave., unit 113
irvin, 
CA 
92614

Correspodent Contact jim-son chou
Regulation Number 886.1850
Classification Product Code
HJO  
Date Received 10/05/2007
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No