Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K200313 |
Device Name |
VIVO |
Applicant |
Catheter Precision, Inc. |
500 International Drive, Suite 255 |
Mt. Olive,
NJ
07828
|
|
Applicant Contact |
Steve Adler |
Correspondent |
Catheter Precision, Inc. |
500 International Drive, Suite 255 |
Mt. Olive,
NJ
07828
|
|
Correspondent Contact |
Steve Adler |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 02/06/2020 |
Decision Date | 09/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|