The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Mylabssogno.
| Device ID | K140677 |
| 510k Number | K140677 |
| Device Name: | MYLABSSOGNO |
| 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 | 2014-03-18 |
| Decision Date | 2014-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869006529 | K140677 | 000 |
| 04056869003436 | K140677 | 000 |
| 04056869003429 | K140677 | 000 |
| 04056869003375 | K140677 | 000 |
| 04056869003368 | K140677 | 000 |
| 04056869003351 | K140677 | 000 |
| 04056869003344 | K140677 | 000 |
| 04056869003313 | K140677 | 000 |
| 04056869003276 | K140677 | 000 |
| 04056869003221 | K140677 | 000 |
| 04056869003443 | K140677 | 000 |
| 04056869004259 | K140677 | 000 |
| 04056869006512 | K140677 | 000 |
| 04056869006505 | K140677 | 000 |
| 04056869006499 | K140677 | 000 |
| 04056869006482 | K140677 | 000 |
| 04056869006475 | K140677 | 000 |
| 04056869006468 | K140677 | 000 |
| 04056869006451 | K140677 | 000 |
| 04056869006444 | K140677 | 000 |
| 04056869006437 | K140677 | 000 |
| 04056869003214 | K140677 | 000 |