The following data is part of a premarket notification filed by Hoffrel Instruments, Inc. with the FDA for Model 518 & 519 Ultrasonoscope W/doppler.
| Device ID | K844916 |
| 510k Number | K844916 |
| Device Name: | MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HOFFREL INSTRUMENTS, INC. 345 WILSON AVE. P.O. BOX 5825 South Norwalk, CT 06854 |
| Contact | Russel L Uphoff |
| Correspondent | Russel L Uphoff HOFFREL INSTRUMENTS, INC. 345 WILSON AVE. P.O. BOX 5825 South Norwalk, CT 06854 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-18 |
| Decision Date | 1985-04-22 |