The following data is part of a premarket notification filed by Oec-diasonics, Inc. with the FDA for 9600 Fluoroscopic Imaging System.
| Device ID | K926056 |
| 510k Number | K926056 |
| Device Name: | 9600 FLUOROSCOPIC IMAGING SYSTEM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | OEC-DIASONICS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Thomas R Meyers |
| Correspondent | Thomas R Meyers OEC-DIASONICS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-01-21 |
| Summary: | summary |