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 |