The following data is part of a premarket notification filed by Esaote with the FDA for Mylabgold.
| Device ID | K110688 |
| 510k Number | K110688 |
| Device Name: | MYLABGOLD |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ESAOTE 11460 N. MERIDIAN ST., STE. 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-11 |
| Decision Date | 2011-06-02 |
| Summary: | summary |