The following data is part of a premarket notification filed by Med-tron Products, Inc. with the FDA for Panoramic Omega Imaging Table.
Device ID | K903988 |
510k Number | K903988 |
Device Name: | PANORAMIC OMEGA IMAGING TABLE |
Classification | Camera, Scintillation (gamma) |
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 | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-29 |
Decision Date | 1990-10-23 |