Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K172011 |
Device Name |
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) |
Applicant |
HMicro, Inc. |
39355 California Street, #303 |
Fremont,
CA
94538
|
|
Applicant Contact |
Kim Tompkins |
Correspondent |
LifeSignals, Inc. |
39355 California Street, Suite 305 |
Fremont,
CA
94538
|
|
Correspondent Contact |
Saravanan Balasubramanlan |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/03/2017 |
Decision Date | 06/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|