The following data is part of a premarket notification filed by Esaote Europe B.v. with the FDA for Mylab40.
| Device ID | K070903 |
| 510k Number | K070903 |
| Device Name: | MYLAB40 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-07-02 |
| Summary: | summary |