The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co.,ltd with the FDA for Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9s, Consona Ni, Consona Nt, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9t, Consona N8, Consona N8 Pro, Consona N8 Super, Consona Or, Consona N8s, Cons.
| Device ID | K221300 |
| 510k Number | K221300 |
| Device Name: | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Cons |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co.,LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen, CN 518057 |
| Contact | Zhang Wei |
| Correspondent | Zhang Wei Shenzhen Mindray Bio-Medical Electronics Co.,LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen, CN 518057 |
| 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 | 2022-05-05 |
| Decision Date | 2022-09-29 |