Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K170973 |
Device Name |
VitalWatch Software User Interface |
Applicant |
VitalConnect, Inc. |
224 Airport Parkway, Suite 300 |
San Jose,
CA
95110
|
|
Applicant Contact |
Kevin Potgieter |
Correspondent |
VitalConnect, Inc. |
224 Airport Parkway, Suite 300 |
San Jose,
CA
95110
|
|
Correspondent Contact |
Kevin Potgieter |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 04/03/2017 |
Decision Date | 06/02/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|