The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Audio Bandwidth Analyzer.
| Device ID | K840402 |
| 510k Number | K840402 |
| Device Name: | AUDIO BANDWIDTH ANALYZER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | D. E. HOKANSON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-31 |
| Decision Date | 1984-05-09 |