The following data is part of a premarket notification filed by Shenzhen Healthcare Electronic Technology Co. Ltd with the FDA for Body Analysis Scale, Model Bg 17.
| Device ID | K110928 |
| 510k Number | K110928 |
| Device Name: | BODY ANALYSIS SCALE, MODEL BG 17 |
| Classification | Analyzer, Body Composition |
| Applicant | SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD 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 | 2011-04-04 |
| Decision Date | 2011-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10077784029494 | K110928 | 000 |
| 20077784022652 | K110928 | 000 |
| 10077784022006 | K110928 | 000 |
| 40077784018918 | K110928 | 000 |
| 10852547004181 | K110928 | 000 |