The following data is part of a premarket notification filed by Lg Electronics with the FDA for Lg Smarthealth.
Device ID | K133997 |
510k Number | K133997 |
Device Name: | LG SMARTHEALTH |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | LG ELECTRONICS 816 CONGRESS AVE. #1400 Austin, TX 78701 |
Contact | Diane Sudduth |
Correspondent | Diane Sudduth LG ELECTRONICS 816 CONGRESS AVE. #1400 Austin, TX 78701 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-27 |
Decision Date | 2014-11-21 |
Summary: | summary |