The following data is part of a premarket notification filed by Bonso Electronics International Inc. with the FDA for Healthometer Professional Body Fat Monitor And Scale, Models Bfm 940, Bfm 945 & Bfm 960.
| Device ID | K030349 |
| 510k Number | K030349 |
| Device Name: | HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 |
| Classification | Analyzer, Body Composition |
| Applicant | BONSO ELECTRONICS INTERNATIONAL INC. 719 A STREET, NE Washington, DC 20002 |
| Contact | Russ Pagano |
| Correspondent | Russ Pagano BONSO ELECTRONICS INTERNATIONAL INC. 719 A STREET, NE Washington, DC 20002 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-03 |
| Decision Date | 2003-05-02 |
| Summary: | summary |