OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1


Device Classification Name

camera, ophthalmic, ac-powered

510(k) Number K110986
Device Name OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
Applicant
OPTOMED OY
hallituskatu 13-17
d 96
oulu, 

FI

90100

Applicant Contact laura piila
Regulation Number 886.1120
Classification Product Code
HKI  
Date Received 04/08/2011
Decision Date 05/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No