The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Body Composition Monitor With Scale, Model Hbf-500.
| Device ID | K062043 |
| 510k Number | K062043 |
| Device Name: | BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 |
| Classification | Analyzer, Body Composition |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Donna Djinovich |
| Correspondent | Donna Djinovich 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 | 2006-07-19 |
| Decision Date | 2006-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796265168 | K062043 | 000 |
| 00073796265144 | K062043 | 000 |
| 00073796265106 | K062043 | 000 |
| 10073796233508 | K062043 | 000 |