The following data is part of a premarket notification filed by S.m.a.i.o with the FDA for Keops Balance Analyzer 3d.
| Device ID | K213975 |
| 510k Number | K213975 |
| Device Name: | KEOPS Balance Analyzer 3D |
| Classification | System, Image Processing, Radiological |
| Applicant | S.M.A.I.O 2 Place Berthe Morisot Saint Priest, FR 69800 |
| Contact | Jean-charles Roussouly |
| Correspondent | Robert A Poggie BioVera, Inc. 65 Promenade Saint Louis Notre Dame De Llle Perrot, CA J7v7p2 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701313000479 | K213975 | 000 |