The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Au6.
| Device ID | K990360 |
| 510k Number | K990360 |
| Device Name: | AU6 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Colleen Hiitle |
| Correspondent | Colleen Hiitle BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-05 |
| Decision Date | 1999-04-30 |
| Summary: | summary |