The following data is part of a premarket notification filed by Cmt Medical Technologies Ltd with the FDA for Artpix Drf.
| Device ID | K202235 |
| 510k Number | K202235 |
| Device Name: | ArtPIX DRF |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | CMT Medical Technologies Ltd 7/2 Hacarmel St., POB 111, Industrial Park Yokneam Ilit, IL 20692 |
| Contact | Dror Wertman |
| Correspondent | Dror Wertman CMT Medical Technologies Ltd 7/2 Hacarmel St., POB 111, Industrial Park Yokneam Ilit, IL 20692 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-07 |
| Decision Date | 2020-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012104909 | K202235 | 000 |