The following data is part of a premarket notification filed by Radiation Measurements, Inc. with the FDA for Doppler Phantom Flow Control Sys.
Device ID | K834481 |
510k Number | K834481 |
Device Name: | DOPPLER PHANTOM FLOW CONTROL SYS |
Classification | Test-pattern, Radiographic |
Applicant | RADIATION MEASUREMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IXF |
CFR Regulation Number | 892.1940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-15 |
Decision Date | 1984-01-25 |