NON-CONTACT TEAR FILM THERMOGRAGH


Device Classification Name

camera, ophthalmic, ac-powered

510(k) Number K111771
Device Name NON-CONTACT TEAR FILM THERMOGRAGH
Applicant
UNITED INTEGRATED SERVICES CO., LTD.
no.58, fu chiun street
hsin chu city, 

TW

30067

Applicant Contact jen ke-min
Correspondent
UNITED INTEGRATED SERVICES CO., LTD.
no.58, fu chiun street
hsin chu city, 

TW

30067

Correspodent Contact jen ke-min
Regulation Number 886.1120
Classification Product Code
HKI  
Date Received 06/23/2011
Decision Date 11/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No