The following data is part of a premarket notification filed by Hoffrel Instruments, Inc. with the FDA for Mod 426, Medical Ultrasonic Diagnostc Transducer.
| Device ID | K860235 |
| 510k Number | K860235 |
| Device Name: | MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-22 |
| Decision Date | 1986-05-15 |