The following data is part of a premarket notification filed by Medisono, Llc with the FDA for Medisono Color Doppler Ultrasound System, Models P11 Portable, P11 Expert Portable, P12 Trolley, P12 Expert, P25 Trolley, And P25 Expert Trolley.
| Device ID | K170078 |
| 510k Number | K170078 |
| Device Name: | Medisono Color Doppler Ultrasound System, Models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, And P25 Expert Trolley |
| 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 | 2017-01-09 |
| Decision Date | 2017-05-17 |
| Summary: | summary |