The following data is part of a premarket notification filed by Sim&cure with the FDA for Sim&size.
| Device ID | K212373 |
| 510k Number | K212373 |
| Device Name: | Sim&Size |
| Classification | Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| Applicant | Sim&Cure 95 Rue Pierre Flourens Bâtiment H Montpellier, FR 34090 |
| Contact | Caroline Oziel |
| Correspondent | Lucile Azema Sim&Cure 95 Rue Pierre Flourens Bâtiment H Montpellier, FR 34090 |
| Product Code | PZO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-30 |
| Decision Date | 2022-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665786000063 | K212373 | 000 |