The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Display Processor - Model Idp5100.
Device ID | K920550 |
510k Number | K920550 |
Device Name: | DISPLAY PROCESSOR - MODEL IDP5100 |
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 | 1992-02-06 |
Decision Date | 1992-04-13 |