The following data is part of a premarket notification filed by Esaote S.p.a with the FDA for 6440 Ultrasound System.
| Device ID | K173291 |
| 510k Number | K173291 |
| Device Name: | 6440 Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Esaote S.p.A Via Enrico Melen 77 Genova, IT 16152 |
| Contact | Massimo Polignano |
| Correspondent | Allison Scott Navigant Consulting, Inc 9100 Keystone Crossing Suite 500 Indianapolis, IN 46240 |
| 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 | 2017-10-16 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304453921 | K173291 | 000 |
| 08056304454676 | K173291 | 000 |