The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Programmable Video Controller Model Pk2060.
Device ID | K904986 |
510k Number | K904986 |
Device Name: | PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 |
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 | 1990-11-02 |
Decision Date | 1990-12-04 |