Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K233750 |
Device Name |
ECG-less Cardiac |
Applicant |
GE Medical Systems, LLC. |
3000 N Grandview Blvd |
Waukesha,
WI
53188
|
|
Applicant Contact |
Katelyn Rowley |
Correspondent |
GE Medical Systems, LLC. |
3000 N Grandview Blvd |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Katelyn Rowley |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/22/2023 |
Decision Date | 04/02/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|