The following data is part of a premarket notification filed by Biospace Corporation Limited with the FDA for Inbody 770, Inbody 570, Inbody S10, Inbody H20/inbody H20(b).
| Device ID | K123228 |
| 510k Number | K123228 |
| Device Name: | INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) |
| 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 | 2012-10-15 |
| Decision Date | 2013-03-08 |
| Summary: | summary |