The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for Mylabgamma.
| Device ID | K142077 |
| 510k Number | K142077 |
| Device Name: | MYLABGAMMA |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ESAOTE, S.P.A. 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268 |
| Contact | Allison Scott |
| Correspondent | Allison Scott ESAOTE, S.P.A. 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268 |
| 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 | 2014-07-31 |
| Decision Date | 2014-09-12 |
| Summary: | summary |