The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Mylabsix Crystaline.
| Device ID | K162290 |
| 510k Number | K162290 |
| Device Name: | MyLabSix CrystaLine |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE S.P.A. VIA A. SIFFREDI 58 Genova, IT 16153 |
| Contact | Massimo Polignano |
| Correspondent | Allison Scott NAVIGANT CONSULTING, INC 9001 WESLEYAN ROAD, SUITE 200 Idianapolis, IN 46268 |
| 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 | 2016-08-15 |
| Decision Date | 2016-10-14 |
| Summary: | summary |