The following data is part of a premarket notification filed by Medicor Usa Ltd. with the FDA for Model Pcx/emy 525a Microprocesssor Control X-ray C.
| Device ID | K850761 |
| 510k Number | K850761 |
| Device Name: | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C |
| Classification | Cart, Emergency, Cardiopulmonary (excluding Equipment) |
| Applicant | MEDICOR USA LTD. 1400 HOLLY AVE. Columbus, OH 43212 |
| Contact | Geza Pataky |
| Correspondent | Geza Pataky MEDICOR USA LTD. 1400 HOLLY AVE. Columbus, OH 43212 |
| Product Code | BZN |
| CFR Regulation Number | 868.6175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-09-19 |