The following data is part of a premarket notification filed by Biospace Co.,ltd with the FDA for Inbody Ap1 Body Composition Analyzer.
| Device ID | K023478 |
| 510k Number | K023478 |
| Device Name: | INBODY AP1 BODY COMPOSITION ANALYZER |
| Classification | Analyzer, Body Composition |
| Applicant | BIOSPACE CO.,LTD PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm BIOSPACE CO.,LTD 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 | 2002-10-16 |
| Decision Date | 2003-05-13 |
| Summary: | summary |