The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Anopress.
| Device ID | K161785 |
| 510k Number | K161785 |
| Device Name: | THD ANOPRESS |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | THD SPA VIA DELL'INDUSTRIA 1 Correggio, IT 42015 |
| Contact | Giuseppina Giannini |
| Correspondent | Maurizio Pantaleoni ISEMED SRL VIA A.BONETTI 3/A Imola, IT 40026 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-29 |
| Decision Date | 2017-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18033737711412 | K161785 | 000 |
| 18033737711245 | K161785 | 000 |
| 08033737711309 | K161785 | 000 |
| 08033737711293 | K161785 | 000 |
| 28033737711372 | K161785 | 000 |
| 28033737711334 | K161785 | 000 |
| 08033737711262 | K161785 | 000 |
| 08033737711255 | K161785 | 000 |