The following data is part of a premarket notification filed by Control-x, Inc. with the FDA for Ba-4 Wall Bucky And Ba-42 Tilting Wall Bucky.
Device ID | K924445 |
510k Number | K924445 |
Device Name: | BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY |
Classification | Holder, Radiographic Cassette, Wall-mounted |
Applicant | CONTROL-X, INC. 2289 WESTBROOKE DR. Columbus, OH 43228 |
Contact | Zsigmond Dovacs |
Correspondent | Zsigmond Dovacs CONTROL-X, INC. 2289 WESTBROOKE DR. Columbus, OH 43228 |
Product Code | IXY |
CFR Regulation Number | 892.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-01 |
Decision Date | 1993-02-19 |