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 | K192210 |
| 510k Number | K192210 |
| 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 | Francesco Batistini |
| 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 | 2019-08-14 |
| Decision Date | 2019-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054953343881 | K192210 | 000 |
| 18058480753991 | K192210 | 000 |
| 08058480754021 | K192210 | 000 |
| 08058480754618 | K192210 | 000 |
| 08058480754700 | K192210 | 000 |
| 08054953344003 | K192210 | 000 |
| 08054953344010 | K192210 | 000 |
| 08054953346335 | K192210 | 000 |
| 18054953343874 | K192210 | 000 |
| 18058480753984 | K192210 | 000 |