The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Pk2025/pk2045 Programmable Video Controller.
| Device ID | K893644 |
| 510k Number | K893644 |
| Device Name: | PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
| Contact | James C Furse |
| Correspondent | James C Furse PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-08-09 |