The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Fat Loss Monitor With Scale, Model Hbf-400.
| Device ID | K043060 |
| 510k Number | K043060 |
| Device Name: | OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 |
| Classification | Analyzer, Body Composition |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Larry Lepley |
| Correspondent | Larry Lepley OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-05 |
| Decision Date | 2005-01-19 |