The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Vert-x Universal Vertical Bucky Stand.
Device ID | K922443 |
510k Number | K922443 |
Device Name: | VERT-X UNIVERSAL VERTICAL BUCKY STAND |
Classification | Holder, Radiographic Cassette, Wall-mounted |
Applicant | AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
Contact | Randal L Hale |
Correspondent | Randal L Hale AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
Product Code | IXY |
CFR Regulation Number | 892.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-22 |
Decision Date | 1992-10-26 |