The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Hl 188 & Hl 189 Body Fat Meter.
| Device ID | K043414 |
| 510k Number | K043414 |
| Device Name: | HL 188 & HL 189 BODY FAT METER |
| Classification | Analyzer, Body Composition |
| Applicant | HEALTH & LIFE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich HEALTH & LIFE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-02-09 |
| Summary: | summary |