The following data is part of a premarket notification filed by Bone Index Finland, Ltd. with the FDA for Bindex Bi-2.
| Device ID | K161971 |
| 510k Number | K161971 |
| Device Name: | Bindex BI-2 |
| Classification | Bone Sonometer |
| Applicant | BONE INDEX FINLAND, LTD. MICROKATU 1 Kuopio, FI 70211 |
| Contact | Janne Karjalainen |
| Correspondent | Janne Karjalainen BONE INDEX FINLAND, LTD. MICROKATU 1 Kuopio, FI 70211 |
| Product Code | MUA |
| CFR Regulation Number | 892.1180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2017-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430065790051 | K161971 | 000 |
| 06430065790044 | K161971 | 000 |
| 06430065790037 | K161971 | 000 |
| 06430065790020 | K161971 | 000 |
| 06430065790013 | K161971 | 000 |