The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Artpix Mobile Ez2go.
| Device ID | K162224 |
| 510k Number | K162224 |
| Device Name: | ArtPix Mobile EZ2GO |
| Classification | System, X-ray, Stationary |
| Applicant | CMT MEDICAL TECHNOLOGIES, LTD. HACARMEL ST. BLD 7/2, POB 111 INDUSTRIAL PARK Yoqneam Ilit, IL 20692 |
| Contact | Lilia Schlosberg |
| Correspondent | Lilia Schlosberg CMT MEDICAL TECHNOLOGIES, LTD. HACARMEL ST. BLD 7/2, POB 111 INDUSTRIAL PARK Yoqneam Ilit, IL 20692 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-08 |
| Decision Date | 2016-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012104602 | K162224 | 000 |
| 07290012104916 | K162224 | 000 |
| 07290012104923 | K162224 | 000 |