The following data is part of a premarket notification filed by Raymax Medical Corp. with the FDA for Video Fluoroscope.
| Device ID | K914414 |
| 510k Number | K914414 |
| Device Name: | VIDEO FLUOROSCOPE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | RAYMAX MEDICAL CORP. 64 TROWERS ROAD WOODBRIDGE Ontario, L4l 7k5, CA |
| Contact | J. B Pritchard |
| Correspondent | J. B Pritchard RAYMAX MEDICAL CORP. 64 TROWERS ROAD WOODBRIDGE Ontario, L4l 7k5, CA |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1992-01-24 |