The following data is part of a premarket notification filed by Fiab Spa with the FDA for Esotest Esophageal Temperature Probe And Temperature Monitoring System.
| Device ID | K123361 |
| 510k Number | K123361 |
| Device Name: | ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FIAB SPA VIA COSTOLI, 4 VICCHIO Firenze, IT 50039 |
| Contact | Francesco Batistini |
| Correspondent | Francesco Batistini FIAB SPA VIA COSTOLI, 4 VICCHIO Firenze, 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 | 2012-10-31 |
| Decision Date | 2013-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08054242448061 | K123361 | 000 |
| 08054242446364 | K123361 | 000 |
| 18054242441922 | K123361 | 000 |