The following data is part of a premarket notification filed by Bts S.p.a. with the FDA for Teethan 2.0.
| Device ID | K161716 |
| 510k Number | K161716 |
| Device Name: | TEETHAN 2.0 |
| Classification | Device, Muscle Monitoring |
| Applicant | BTS S.P.A. VIA DELLA CROCE ROSSA 11 Padova, IT 35129 |
| Contact | Veronica Bartolini |
| Correspondent | Julie Sherman NAMSA 4050 OLSON MEMORIAL HIGHWAY, SUITE 450 Minneapolis, MN 55422 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-21 |
| Decision Date | 2016-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B179THN1 | K161716 | 000 |