Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K113350 |
Device Name |
BRIVO NM 615 |
Applicant |
GE HEALTHCARE |
4 HAYOZMA STREET |
TIRAT HACARMEL,
IL
30200
|
|
Applicant Contact |
ELI WERNER |
Correspondent |
GE HEALTHCARE |
4 HAYOZMA STREET |
TIRAT HACARMEL,
IL
30200
|
|
Correspondent Contact |
ELI WERNER |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/14/2011 |
Decision Date | 12/05/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|