The following data is part of a premarket notification filed by Raymax Medical Corp. with the FDA for Raymax 2100 Models 2130 & 2136.
| Device ID | K883431 |
| 510k Number | K883431 |
| Device Name: | RAYMAX 2100 MODELS 2130 & 2136 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | RAYMAX MEDICAL CORP. 64 TROWERS ROAD WOODBRIDGE Ontario, L4l 7k5, CA |
| Contact | Pritchard |
| Correspondent | Pritchard RAYMAX MEDICAL CORP. 64 TROWERS ROAD WOODBRIDGE Ontario, L4l 7k5, CA |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-09-12 |