Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K152139 |
FOIA Releasable 510(k) |
K152139
|
Device Name |
Vital Connect Platform, HealthPatch MD, VitalPatch |
Applicant |
VITAL CONNECT, INC. |
900 E. HAMILTON AVENUE, SUITE 500 |
CAMPBELL,
CA
95008
|
|
Applicant Contact |
BONNIE WU |
Correspondent |
VITAL CONNECT, INC. |
900 E. HAMILTON AVENUE, SUITE 500 |
CAMPBELL,
CA
95008
|
|
Correspondent Contact |
BONNIE WU |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/03/2015 |
Decision Date | 12/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|