Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K193343 |
Device Name |
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) |
Applicant |
VitalConnect, Inc. |
224 Airport Parkway, Suite 300 |
San Jose,
CA
95110
|
|
Applicant Contact |
Cynthia Merrell |
Correspondent |
VitalConnect, Inc. |
224 Airport Parkway, Suite 300 |
San Jose,
CA
95110
|
|
Correspondent Contact |
Cynthia Merrell |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 12/03/2019 |
Decision Date | 04/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|