Device Classification Name |
Electrocardiograph
|
510(k) Number |
K201456 |
Device Name |
Scan Monitor |
Applicant |
Withings SA |
2 rue Maurice Hartmann |
Issy-Les-Moulineaux,
FR
92130
|
|
Applicant Contact |
Debreuil Xavier |
Correspondent |
Withings SA |
2 rue Maurice Hartmann |
Issy-Les-Moulineaux,
FR
92130
|
|
Correspondent Contact |
Debreuil Xavier |
Regulation Number | 870.2340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/01/2020 |
Decision Date | 10/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04351386
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|