The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Au5 Ultrasound Imaging System.
| Device ID | K980468 |
| 510k Number | K980468 |
| Device Name: | AU5 ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Colleen Hittle |
| Correspondent | Colleen Hittle 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 | 1998-02-06 |
| Decision Date | 1998-08-26 |
| Summary: | summary |