P200T


Device Classification Name

ophthalmoscope,laser,scanning

510(k) Number K111628
Device Name P200T
Applicant
OPTOS PLC
555 thirteenth street, nw
washington, 
DC 
20004

Applicant Contact howard m holstein
Correspondent
OPTOS PLC
555 thirteenth street, nw
washington, 
DC 
20004

Correspodent Contact howard m holstein
Regulation Number 886.1570
Classification Product Code
MYC  
Date Received 06/10/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No