Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K183078 |
Device Name |
VitalConnect Platform, VitalPatch Biosensor |
Applicant |
VitalConnect, Inc. |
224 Airport Parkway, Suite 300 |
San Jose,
CA
95110
|
|
Applicant Contact |
Cynthia Merrell |
Correspondent |
Medical Device Academy, Inc. |
345 Lincoln Hill Road |
Shrewsbury,
VT
05738
|
|
Correspondent Contact |
Robert Packard |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/05/2018 |
Decision Date | 03/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|