The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for 7350 Ultrasound Imaging System, Model 7350.
| Device ID | K050326 |
| 510k Number | K050326 |
| Device Name: | 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 |
| 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 | 2005-02-09 |
| Decision Date | 2005-02-28 |
| Summary: | summary |