The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for Mylabtwice, Model 6200.
| Device ID | K100931 |
| 510k Number | K100931 |
| Device Name: | MYLABTWICE, MODEL 6200 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE, S.P.A. 11460 N MERIDIAN ST., STE 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Allison Scott 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 | 2010-04-05 |
| Decision Date | 2010-06-25 |
| Summary: | summary |