The following data is part of a premarket notification filed by Biospace Corporation Limited with the FDA for Biospace Body Composition Analyzers, Model Inbody 230.
| Device ID | K062603 |
| 510k Number | K062603 |
| Device Name: | BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 |
| Classification | Analyzer, Body Composition |
| Applicant | BIOSPACE CORPORATION LIMITED PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm BIOSPACE CORPORATION LIMITED PO BOX 7007 Deerfield, IL 60015 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2007-02-15 |
| Summary: | summary |