The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for My Labs25 Gold/mylab30 Gold Cardiovascular Model 7340, My Lab70/my Lab70xvision/mylab60, Model 6150.
| Device ID | K091009 |
| 510k Number | K091009 |
| Device Name: | MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE S.P.A. 11460 N. MERIDIAN ST. 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 | 2009-04-09 |
| Decision Date | 2009-05-18 |
| Summary: | summary |