The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Duet Drf.
| Device ID | K103038 |
| 510k Number | K103038 |
| Device Name: | DUET DRF |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| 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 | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-14 |
| Decision Date | 2011-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012104701 | K103038 | 000 |