Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K212345 |
Device Name |
AcQMap High Resolution Imaging and Mapping System |
Applicant |
Acutus Medical, Inc. |
2210 Faraday Ave, Suite 100 |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Sindhu Sridhar |
Correspondent |
Acutus Medical, Inc. |
2210 Faraday Ave, Suite 100 |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Sindhu Sridhar |
Regulation Number | 870.1425
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/28/2021 |
Decision Date | 08/27/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|