The following data is part of a premarket notification filed by Esaote Europe B.v. with the FDA for Mylabone Ultrasound System.
| Device ID | K101605 |
| 510k Number | K101605 |
| Device Name: | MYLABONE ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 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 | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2010-08-31 |
| Summary: | summary |