The following data is part of a premarket notification filed by D&r X-ray Products, Inc. with the FDA for Collimator Model A280ble & Model A280-blm.
| Device ID | K861942 |
| 510k Number | K861942 |
| Device Name: | COLLIMATOR MODEL A280BLE & MODEL A280-BLM |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | D&R X-RAY PRODUCTS, INC. 2428 HANOVER AVE. Richmond, VA 23220 |
| Contact | David P Armstrong |
| Correspondent | David P Armstrong D&R X-RAY PRODUCTS, INC. 2428 HANOVER AVE. Richmond, VA 23220 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-07-25 |