The following data is part of a premarket notification filed by Esaote Europe B.v. with the FDA for Mylab15/20 New Indications Ultrasound System.
| Device ID | K061755 |
| 510k Number | K061755 |
| Device Name: | MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Contact | Carri Graham |
| Correspondent | Carri Graham ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| 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 | No |
| Combination Product | No |
| Date Received | 2006-06-21 |
| Decision Date | 2006-08-07 |
| Summary: | summary |