CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES


Device Classification Name

confocal optical imaging

510(k) Number K111047
Device Name CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
Applicant
MAUNA KEA TECHNOLOGIES INC.
660 newtown-yardley rd.
suite 107
newton, 
PA 
18940

Applicant Contact chris tihansky
Regulation Number 876.1500
Classification Product Code
OWN  
Date Received 04/15/2011
Decision Date 08/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

No