The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for 6400 Ultrasound System (mylabx6, Mylabx7).
| Device ID | K190989 |
| 510k Number | K190989 |
| Device Name: | 6400 Ultrasound System (MyLabX6, MyLabX7) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Esaote, S.p.A. Via Enrico Melen 77 Genova, IT 16152 |
| Contact | Piet De Jong |
| Correspondent | Piet De Jong Esaote, S.p.A. Via Enrico Melen 77 Genova, IT 16152 |
| 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 | 2019-04-15 |
| Decision Date | 2019-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304453525 | K190989 | 000 |
| 08056304453518 | K190989 | 000 |