The following data is part of a premarket notification filed by Bone Index Finland Ltd. with the FDA for Bindex Bi-2.
| Device ID | K211350 |
| 510k Number | K211350 |
| Device Name: | Bindex BI-2 |
| Classification | Bone Sonometer |
| Applicant | Bone Index Finland Ltd. Savilahdentie 14 Kuopio, FI 70700 |
| Contact | Janne Karjalainen |
| Correspondent | Janne Karjalainen Bone Index Finland Ltd. Savilahdentie 14 Kuopio, FI 70700 |
| Product Code | MUA |
| CFR Regulation Number | 892.1180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2022-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430065790068 | K211350 | 000 |