The following data is part of a premarket notification filed by Med-tron Products, Inc. with the FDA for Xyz Crank Imaging Table.
Device ID | K911691 |
510k Number | K911691 |
Device Name: | XYZ CRANK IMAGING TABLE |
Classification | Bed, Scanning, Nuclear |
Applicant | MED-TRON PRODUCTS, INC. P.O. BOX 866 Miller Place, NY 11764 |
Contact | Katherine Maguill |
Correspondent | Katherine Maguill MED-TRON PRODUCTS, INC. P.O. BOX 866 Miller Place, NY 11764 |
Product Code | IYZ |
CFR Regulation Number | 892.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-16 |
Decision Date | 1991-08-09 |