The following data is part of a premarket notification filed by Medisono, Llc with the FDA for Medisono Ultrasonic Diagnostic Imaging System, Models P1, P3, And P10.
| Device ID | K163688 |
| 510k Number | K163688 |
| Device Name: | Medisono Ultrasonic Diagnostic Imaging System, Models P1, P3, And P10 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISONO, LLC 3511 SILVERSIDE RD STE 105 Wilmington, DE 19810 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan HIATEC 601 WEST 20 ST Hialeah, FL 33010 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-28 |
| Decision Date | 2017-02-23 |
| Summary: | summary |