The following data is part of a premarket notification filed by Bts Spa with the FDA for Smart (smart-d, Smart-dx).
| Device ID | K131660 |
| 510k Number | K131660 |
| Device Name: | SMART (SMART-D, SMART-DX) |
| Classification | System, Optical Position/movement Recording |
| Applicant | BTS SPA VIA CROCE ROSSA, 11 Padova, IT 35129 |
| Contact | Enrico Bisson |
| Correspondent | Enrico Bisson BTS SPA VIA CROCE ROSSA, 11 Padova, IT 35129 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-06 |
| Decision Date | 2014-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B179SDX | K131660 | 000 |
| B179SDXEVO1 | K131660 | 000 |