The following data is part of a premarket notification filed by Med-tron Products, Inc. with the FDA for Full View Omega Table.
Device ID | K905827 |
510k Number | K905827 |
Device Name: | FULL VIEW OMEGA 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 | 1990-12-31 |
Decision Date | 1991-01-28 |