Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K133997 |
FOIA Releasable 510(k) |
K133997
|
Device Name |
LG SMARTHEALTH |
Applicant |
LG ELECTRONICS |
816 CONGRESS AVE. #1400 |
AUSTIN,
TX
78701
|
|
Applicant Contact |
DIANE SUDDUTH |
Correspondent |
LG ELECTRONICS |
816 CONGRESS AVE. #1400 |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
DIANE SUDDUTH |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 12/27/2013 |
Decision Date | 11/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|