The following data is part of a premarket notification filed by Navigant Consulting - On Behalf Of Esaote S.p.a. with the FDA for 7400 Ultrasound Systems.
| Device ID | K190447 |
| 510k Number | K190447 |
| Device Name: | 7400 Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Navigant Consulting - On Behalf Of Esaote S.p.A. 9100 Keystone Crossing Suite 500 Indianapolis, IN 46240 |
| Contact | Allison Scott |
| Correspondent | Allison Scott Navigant Consulting - On Behalf Of Esaote S.p.A. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304453617 | K190447 | 000 |
| 08056304455031 | K190447 | 000 |