The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Temporomanibular Coil 15.
| Device ID | K110373 |
| 510k Number | K110373 |
| Device Name: | TEMPOROMANIBULAR COIL 15 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | ESAOTE S.P.A. VIA SIFFREDI 58 Genova, IT 16153 |
| Contact | Donatella Ragghianti |
| Correspondent | Donatella Ragghianti ESAOTE S.P.A. VIA SIFFREDI 58 Genova, IT 16153 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-08 |
| Decision Date | 2011-04-06 |
| Summary: | summary |