Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K231870 |
Device Name |
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System |
Applicant |
GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Manjunatha K N |
Correspondent |
GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Manjunatha K N |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 06/26/2023 |
Decision Date | 12/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|