The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Wi-fi Body Scale.
Device ID | K120896 |
510k Number | K120896 |
Device Name: | WI-FI BODY SCALE |
Classification | Analyzer, Body Composition |
Applicant | ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
Contact | Liu Yi |
Correspondent | Liu Yi ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
Product Code | MNW |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-26 |
Decision Date | 2012-07-26 |
Summary: | summary |