The following data is part of a premarket notification filed by Diamed Division Ill. Tool Works, Inc. with the FDA for Diamed Models 600, 900, 960, 964.
| Device ID | K854953 |
| 510k Number | K854953 |
| Device Name: | DIAMED MODELS 600, 900, 960, 964 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | DIAMED DIVISION ILL. TOOL WORKS, INC. 23322 SOUTH POINTE DR., STE. E Laguna Hills, CA 92653 |
| Contact | Robert J Brasher |
| Correspondent | Robert J Brasher DIAMED DIVISION ILL. TOOL WORKS, INC. 23322 SOUTH POINTE DR., STE. E Laguna Hills, CA 92653 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-10 |
| Decision Date | 1986-04-22 |