Device Classification Name |
insufflator, automatic carbon-dioxide for endoscope
|
510(k) Number |
K123047 |
Device Name |
BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET |
Applicant |
BRACCO DIAGNOSTIC, INC. |
107 COLLEGE ROAD |
PRINCETON,
NJ
08540
|
|
Applicant Contact |
TRACEY ALEXANDER |
Correspondent |
BRACCO DIAGNOSTIC, INC. |
107 COLLEGE ROAD |
PRINCETON,
NJ
08540
|
|
Correspondent Contact |
TRACEY ALEXANDER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/28/2012 |
Decision Date | 08/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|