BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR


Device Classification Name

insufflator, automatic carbon-dioxide for endoscope

510(k) Number K111648
Device Name BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
Applicant
BRACCO DIAGNOSTIC, INC.
532 broadhollow road
suite 126
melville, 
NY 
11747

Applicant Contact tracey alexander
Correspondent
BRACCO DIAGNOSTIC, INC.
532 broadhollow road
suite 126
melville, 
NY 
11747

Correspodent Contact tracey alexander
Regulation Number 876.1500
Classification Product Code
FCX  
Date Received 06/13/2011
Decision Date 11/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No