The following data is part of a premarket notification filed by Hoffrel Instruments, Inc. with the FDA for Motor Drive, Mechanical Sector Scanning-mod417.
| Device ID | K850165 |
| 510k Number | K850165 |
| Device Name: | MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 |
| Classification | Transducer, 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 | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-16 |
| Decision Date | 1985-10-23 |