Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K192757 |
Device Name |
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 |
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 |
|
Subsequent Product Codes |
|
Date Received | 09/30/2019 |
Decision Date | 02/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|