Device Classification Name |
electrocardiograph
|
510(k) Number |
K212112 |
Device Name |
Cardiologs Holter Platform |
Applicant |
Cardiologs Technologies |
136 Rue Saint Denis |
Paris,
FR
75002
|
|
Applicant Contact |
Arezou Azar |
Correspondent |
Cardiologs Technologies |
136 Rue Saint Denis |
Paris,
FR
75002
|
|
Correspondent Contact |
Arezou Azar |
Regulation Number | 870.2340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/06/2021 |
Decision Date | 11/18/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|