The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Mitek Arthroscopes.
| Device ID | K133941 |
| 510k Number | K133941 |
| Device Name: | MITEK ARTHROSCOPES |
| Classification | Arthroscope |
| Applicant | MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38, CASE POSTALE Le Locle, CH Ch 2400 |
| Contact | Susan Kagan |
| Correspondent | Susan Kagan MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38, CASE POSTALE Le Locle, CH 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 | 2013-12-23 |
| Decision Date | 2014-04-18 |
| Summary: | summary |