The following data is part of a premarket notification filed by Midwest X-ray Equipment Co. with the FDA for Mwx-7440 High Speed Bucky.
Device ID | K924423 |
510k Number | K924423 |
Device Name: | MWX-7440 HIGH SPEED BUCKY |
Classification | Changer, Radiographic Film/cassette |
Applicant | MIDWEST X-RAY EQUIPMENT CO. 701 W. ILLINIOS AVE. Aurora, IL 60506 |
Contact | Robert Brown |
Correspondent | Robert Brown MIDWEST X-RAY EQUIPMENT CO. 701 W. ILLINIOS AVE. Aurora, IL 60506 |
Product Code | KPX |
CFR Regulation Number | 892.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-01 |
Decision Date | 1993-01-15 |