The following data is part of a premarket notification filed by Fiab Spa with the FDA for Esotest Multi Esophageal Temperature Probe And Temperature Monitoring System.
| Device ID | K180047 |
| 510k Number | K180047 |
| Device Name: | ESOTEST MULTI Esophageal Temperature Probe And Temperature Monitoring System |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Fiab SpA Via Costoli, 4 Vicchio, IT 50039 |
| Contact | Alberto Calabro |
| Correspondent | Francesco Batistini Fiab SpA Via Costoli, 4 Vicchio, IT 50039 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-08 |
| Decision Date | 2018-11-08 |
| Summary: | summary |