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
|
|
Correspondent Contact |
TRACEY ALEXANDER |
Regulation Number | 876.1500
|
Classification Product Code |
|
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
|
Recalls |
CDRH Recalls
|
|
|