The following data is part of a premarket notification filed by Shenzhen Belter Health Measurement And Analysis Te with the FDA for Body Fat Scale Model Sf-371.
| Device ID | K122976 |
| 510k Number | K122976 |
| Device Name: | BODY FAT SCALE MODEL SF-371 |
| Classification | Analyzer, Body Composition |
| Applicant | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-26 |
| Decision Date | 2013-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854067005269 | K122976 | 000 |
| 06947468544575 | K122976 | 000 |
| 06947468544568 | K122976 | 000 |
| 26947468500384 | K122976 | 000 |