The following data is part of a premarket notification filed by Biospace Corporation Limited with the FDA for Biospace Body Composition Analyzer.
| Device ID | K141483 |
| 510k Number | K141483 |
| Device Name: | BIOSPACE BODY COMPOSITION ANALYZER |
| Classification | Analyzer, Body Composition |
| Applicant | BIOSPACE CORPORATION LIMITED 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm BIOSPACE CORPORATION LIMITED 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-05 |
| Decision Date | 2014-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809209591683 | K141483 | 000 |
| 08809209591676 | K141483 | 000 |
| 08809209590976 | K141483 | 000 |