KOWA VX-20


Device Classification Name

camera, ophthalmic, ac-powered

510(k) Number K112330
Device Name KOWA VX-20
Applicant
KOWA CO. LTD.
4-14, nihonbashi-honcho
3-chome, chuo-ku
tokyo, 

JP

103-8433

Applicant Contact hiroyuki koide
Correspondent
KOWA CO. LTD.
4-14, nihonbashi-honcho
3-chome, chuo-ku
tokyo, 

JP

103-8433

Correspodent Contact hiroyuki koide
Regulation Number 886.1120
Classification Product Code
HKI  
Subsequent Product Code
NFJ  
Date Received 08/12/2011
Decision Date 02/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No