The following data is part of a premarket notification filed by Esaote Biomedica Spa with the FDA for Au530 Diagnostic Ultrasonic Pulsed Echo System.
| Device ID | K896356 |
| 510k Number | K896356 |
| Device Name: | AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ESAOTE BIOMEDICA SPA C/O PAREXEL INTERNATIONAL CORP ONE ALEWIFE PLACE Cambridge, MA 02140 |
| Contact | Sayigh, Phd |
| Correspondent | Sayigh, Phd ESAOTE BIOMEDICA SPA C/O PAREXEL INTERNATIONAL CORP ONE ALEWIFE PLACE Cambridge, MA 02140 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1990-08-21 |