Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K183195 |
Device Name |
VIVO |
Applicant |
Catheter Precision, Inc. |
1705 Route 46 |
Ledgewood,
NJ
07852
|
|
Applicant Contact |
Steve Adler |
Correspondent |
Catheter Precision, Inc. |
1705 Route 46 |
Ledgewood,
NJ
07852
|
|
Correspondent Contact |
Karen Bannick |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 11/19/2018 |
Decision Date | 06/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03340142
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|