The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Body Fat Analyzer, Model Hbf-306.
| Device ID | K011652 |
| 510k Number | K011652 |
| Device Name: | BODY FAT ANALYZER, MODEL HBF-306 |
| Classification | Analyzer, Body Composition |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Osamu Shirasaki |
| Correspondent | Osamu Shirasaki OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-29 |
| Decision Date | 2001-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796306342 | K011652 | 000 |
| 00073796306304 | K011652 | 000 |