The following data is part of a premarket notification filed by Precise Optics with the FDA for Phf20 20 Mobile C-arm Image Intensifier.
| Device ID | K935580 |
| 510k Number | K935580 |
| Device Name: | PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | PRECISE OPTICS 239 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Contact | Ron Hannington |
| Correspondent | Ron Hannington PRECISE OPTICS 239 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-03-16 |