The following data is part of a premarket notification filed by Magnetic Research, Inc. with the FDA for Telerad Stat.
Device ID | K931795 |
510k Number | K931795 |
Device Name: | TELERAD STAT |
Classification | System, Digital Image Communications, Radiological |
Applicant | MAGNETIC RESEARCH, INC. 42 NORTH UNIVERSITY AVE. SUITE 204 Provo, UT 84601 |
Contact | Wendell Gibby |
Correspondent | Wendell Gibby MAGNETIC RESEARCH, INC. 42 NORTH UNIVERSITY AVE. SUITE 204 Provo, UT 84601 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-12 |
Decision Date | 1993-11-19 |