FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H


Device Classification Name

bronchoscope (flexible or rigid)

510(k) Number K122535
Device Name FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 high point drive
wayne, 
NJ 
07470

Regulation Number 874.4680
Classification Product Code
EOQ  
Date Received 08/20/2012
Decision Date 12/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No