The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Prestodr Portable.
| Device ID | K100400 |
| 510k Number | K100400 |
| Device Name: | PRESTODR PORTABLE |
| Classification | System, X-ray, Mobile |
| Applicant | CMT MEDICAL TECHNOLOGIES, LTD. HACARMEL ST BUILDING 7/2 P.O.B. 111 Yoqneam Ilit, IL 20692 |
| Contact | Shlomi Dines |
| Correspondent | Shlomi Dines CMT MEDICAL TECHNOLOGIES, LTD. HACARMEL ST BUILDING 7/2 P.O.B. 111 Yoqneam Ilit, IL 20692 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-04-22 |
| Summary: | summary |