The following data is part of a premarket notification filed by Radiation Measurements, Inc. with the FDA for Rmi Ultrasound Doppler Phantom System.
Device ID | K893216 |
510k Number | K893216 |
Device Name: | RMI ULTRASOUND DOPPLER PHANTOM SYSTEM |
Classification | Block, Test, Ultrasonic Scanner Calibration |
Applicant | RADIATION MEASUREMENTS, INC. P.O. BOX 327 7617 DONNA DRIVE Middleton, WI 53562 |
Contact | Marie Jennaro |
Correspondent | Marie Jennaro RADIATION MEASUREMENTS, INC. P.O. BOX 327 7617 DONNA DRIVE Middleton, WI 53562 |
Product Code | GXX |
CFR Regulation Number | 882.1925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-27 |
Decision Date | 1989-09-05 |