The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Revolution.
| Device ID | K141657 |
| 510k Number | K141657 |
| Device Name: | THD REVOLUTION |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | THD SPA VIA A. BONETTI 3/A Imola, Bo, IT 40026 |
| Contact | Maurizio Pantaleoni |
| Correspondent | Maurizio Pantaleoni THD SPA VIA A. BONETTI 3/A Imola, Bo, IT 40026 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-20 |
| Decision Date | 2015-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18033737710842 | K141657 | 000 |