Device Classification Name |
electrocardiograph
|
510(k) Number |
K221321 |
Device Name |
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System |
Applicant |
GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Honghong Yang |
Correspondent |
GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Honghong Yang |
Regulation Number | 870.2340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/06/2022 |
Decision Date | 10/18/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|