The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for Mylab30, 50, 70 And 90 Systems Addition Of 3d/4d, Models 7300, 7350, 6150, 6100.
| Device ID | K060827 |
| 510k Number | K060827 |
| Device Name: | MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE, S.P.A. 11460 N MERIDIAN ST., STE 150 Carmel, IN 46032 |
| Contact | Carri Graham |
| Correspondent | Carri Graham ESAOTE, S.P.A. 11460 N MERIDIAN ST., STE 150 Carmel, IN 46032 |
| 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 | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2006-05-19 |
| Summary: | summary |