The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Teligen System.
| Device ID | K213978 |
| 510k Number | K213978 |
| Device Name: | TELIGEN System |
| Classification | Arthroscope |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Daria Bochenek |
| Correspondent | Daria Bochenek Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034571607 | K213978 | 000 |
| 10705034560526 | K213978 | 000 |
| 10705034560359 | K213978 | 000 |