The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Anopress With Thd Sensyprobe.
| Device ID | K180135 |
| 510k Number | K180135 |
| Device Name: | THD Anopress With THD SensyProbe |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | THD SpA Via Dell'Industria 1 Correggio, IT 42015 |
| Contact | Maurizio Pantaleoni |
| Correspondent | Maurizio Pantaleoni THD SpA Via Dell'Industria 1 Correggio, IT 42015 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-17 |
| Decision Date | 2018-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033737712306 | K180135 | 000 |
| 08033737712290 | K180135 | 000 |