The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for Mylabsogno.
| Device ID | K121384 |
| 510k Number | K121384 |
| Device Name: | MYLABSOGNO |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE, S.P.A. 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 |
| Contact | Allison Scott, Rac |
| Correspondent | Allison Scott, Rac ESAOTE, S.P.A. 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-08 |
| Decision Date | 2012-05-23 |
| Summary: | summary |