The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Video Enhancement Unit.
Device ID | K954222 |
510k Number | K954222 |
Device Name: | VIDEO ENHANCEMENT UNIT |
Classification | System, Image Processing, Radiological |
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 | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-11 |
Decision Date | 1995-12-08 |