The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Prestodr 4143.
| Device ID | K110849 |
| 510k Number | K110849 |
| Device Name: | PRESTODR 4143 |
| Classification | System, X-ray, Stationary |
| Applicant | CMT MEDICAL TECHNOLOGIES, LTD. INDUSTRIAL PARK P.O.B. 111 Yoqneam Ilit, IL 20692 |
| Contact | Shlomi Dines |
| Correspondent | Shlomi Dines CMT MEDICAL TECHNOLOGIES, LTD. INDUSTRIAL PARK P.O.B. 111 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 | 2011-03-28 |
| Decision Date | 2011-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012104824 | K110849 | 000 |
| 07290012104817 | K110849 | 000 |
| 07290012104800 | K110849 | 000 |