The following data is part of a premarket notification filed by Sim&cure with the FDA for Sim&size.
| Device ID | K190049 |
| 510k Number | K190049 |
| Device Name: | Sim&Size |
| Classification | Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| Applicant | Sim&Cure 1682 Rue De La Valsiere Grabels, FR 34790 |
| Contact | Krishna Mahadea |
| Correspondent | Scott Blood MEDIcept, LLC 22 Nichols Street #2 Salem, MA 01970 |
| Product Code | PZO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-10 |
| Decision Date | 2019-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665786000025 | K190049 | 000 |