The following data is part of a premarket notification filed by Simbionix Ltd. with the FDA for Procedure Rehearsal Studio(tm).
| Device ID | K112387 |
| 510k Number | K112387 |
| Device Name: | PROCEDURE REHEARSAL STUDIO(TM) |
| Classification | System, Image Processing, Radiological |
| Applicant | SIMBIONIX LTD. 1914 J N PEASE PL. Charlotte, NC 28262 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman SIMBIONIX LTD. 1914 J N PEASE PL. Charlotte, NC 28262 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-18 |
| Decision Date | 2011-12-27 |
| Summary: | summary |