The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Consona N6, Consona N6 Pro, Consona N6 Super, Consona Ar, Consona N6s, Consona Ae, Consona At, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6t Diagnostic Ultrasound System.
| Device ID | K221496 |
| 510k Number | K221496 |
| Device Name: | Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System |
| 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 | 2022-05-23 |
| Decision Date | 2022-09-29 |