PANOPTIC


Device Classification Name

camera, ophthalmic, ac-powered

510(k) Number K121405
Device Name PANOPTIC
Applicant
WELCH ALLYN, INC.
4341 state st. rd.
po box 220
skaneateles falls, 
NY 
13153 -0020

Applicant Contact kevin crossen
Correspondent
WELCH ALLYN, INC.
4341 state st. rd.
po box 220
skaneateles falls, 
NY 
13153 -0020

Correspodent Contact kevin crossen
Regulation Number 886.1120
Classification Product Code
HKI  
Date Received 05/10/2012
Decision Date 12/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No