The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Ultrasound Imaging System, Model 7300.
| Device ID | K040596 |
| 510k Number | K040596 |
| Device Name: | ULTRASOUND IMAGING SYSTEM, MODEL 7300 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Carri Graham |
| Correspondent | Carri Graham ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-03-31 |
| Summary: | summary |