The following data is part of a premarket notification filed by Shenzhen Healthcare Electronic Technology Co. Ltd with the FDA for Wi-fi Body Scale.
Device ID | K121527 |
510k Number | K121527 |
Device Name: | WI-FI BODY SCALE |
Classification | Analyzer, Body Composition |
Applicant | SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD NO. 3. JINPING ROAD YA'AN STREET, NANKAI DISTRICT Tianjin, CN 300190 |
Contact | Yang Wang |
Correspondent | Yang Wang SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD NO. 3. JINPING ROAD YA'AN STREET, 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 | 2012-05-23 |
Decision Date | 2012-06-28 |
Summary: | summary |