The following data is part of a premarket notification filed by Esaote Europe B.v. with the FDA for Mylabsix Ultrasound System.
| Device ID | K161168 |
| 510k Number | K161168 |
| Device Name: | MyLabSix Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Esaote Europe B.V. Philipsweg 1 Maastricht, NL 6227 Aj |
| Contact | Bert Vorstenbosch |
| Correspondent | Allison Scott Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 Indianapolis, 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 | 2016-04-26 |
| Decision Date | 2016-09-02 |
| Summary: | summary |