Device Classification Name |
electrocardiograph
|
510(k) Number |
K203786 |
Device Name |
MAC 7 - Resting ECG Analysis System |
Applicant |
GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Lee Bush |
Correspondent |
GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Lee Bush |
Regulation Number | 870.2340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/28/2020 |
Decision Date | 04/30/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|