The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for 6430 Mylabx75, 6430 Mylab Xpro75.
| Device ID | K212021 |
| 510k Number | K212021 |
| Device Name: | 6430 MyLabX75, 6430 MyLab XPro75 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Esaote S.p.A. Via Enrico Melen 77 Genoa, IT 16152 |
| Contact | Alberto Carcagni |
| Correspondent | Alberto Carcagni Esaote S.p.A. Via Enrico Melen 77 Genoa, IT 16152 |
| 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 | 2021-06-28 |
| Decision Date | 2021-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304454386 | K212021 | 000 |