The following data is part of a premarket notification filed by U.s. Imaging, Inc. with the FDA for Pulsed Fluoroscopic Control Model:pf-02.
| Device ID | K882358 |
| 510k Number | K882358 |
| Device Name: | PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 |
| Classification | System, X-ray, Angiographic |
| Applicant | U.S. IMAGING, INC. 4816 MASSILLON RD. Greensburg, OH 44232 |
| Contact | Martin J Kulis |
| Correspondent | Martin J Kulis U.S. IMAGING, INC. 4816 MASSILLON RD. Greensburg, OH 44232 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-07 |
| Decision Date | 1988-10-19 |