The following data is part of a premarket notification filed by Control-x, Inc. with the FDA for B-4 Four-way Radiographic Table.
Device ID | K924444 |
510k Number | K924444 |
Device Name: | B-4 FOUR-WAY RADIOGRAPHIC TABLE |
Classification | Table, Radiographic, Non-tilting, Powered |
Applicant | CONTROL-X, INC. 2289 WESTBROOKE DR. Columbus, OH 43228 |
Contact | Zsigmond Kovacs |
Correspondent | Zsigmond Kovacs CONTROL-X, INC. 2289 WESTBROOKE DR. Columbus, OH 43228 |
Product Code | IZZ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-01 |
Decision Date | 1993-02-05 |