Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K201208 |
Device Name |
Halo AF Detection System |
Applicant |
LIVMOR |
16470 Bake Pkwy., Ste. 200 |
Irvine,
CA
92618
|
|
Applicant Contact |
Ken Persen |
Correspondent |
LIVMOR |
16470 Bake Pkwy., Ste. 200 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Ken Persen |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 05/05/2020 |
Decision Date | 09/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|