The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Resona I9, Resona I9 Exp, Resona I9s, Resona I9t, Resona I9 Easi, Resona I9 Nasa, Resona Iv, Imagyn I9, Imagyn I9s, Imagyn I9 Easi, Nuewa I9, Nuewa I9s, Nuewa I9t, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound.
| Device ID | K210699 |
| 510k Number | K210699 |
| Device Name: | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Shenzhen, CN 518057 |
| Contact | Hao Yixuan |
| Correspondent | Hao Yixuan Shenzhen Mindray Bio-Medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan 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 | 2021-03-09 |
| Decision Date | 2021-06-10 |