The following data is part of a premarket notification filed by Essebi Medical Srl with the FDA for Totim Patient Cushion Immobilization System.
| Device ID | K190894 |
| 510k Number | K190894 |
| Device Name: | TOTIM Patient Cushion Immobilization System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Essebi Medical SRL Strada Campo Del Fiume 84 Faetano, SM 47896 |
| Contact | Pietro Sordina |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-05 |
| Decision Date | 2019-04-30 |