The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Hbf-1000 Omron Body Composition Analyzer.
| Device ID | K963575 |
| 510k Number | K963575 |
| Device Name: | HBF-1000 OMRON BODY COMPOSITION ANALYZER |
| Classification | Analyzer, Body Composition |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Edward Siemens |
| Correspondent | Edward Siemens 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 | 1996-09-06 |
| Decision Date | 1997-06-13 |