The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for Mylab 90 Ultrasound Imaging System, Model 6100.
| Device ID | K051837 |
| 510k Number | K051837 |
| Device Name: | MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE, S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Carri Graham |
| Correspondent | Carri Graham ESAOTE, S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| 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 | 2005-07-06 |
| Decision Date | 2005-07-20 |
| Summary: | summary |