The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor.
| Device ID | K221113 |
| 510k Number | K221113 |
| Device Name: | Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., LTD Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Contact | Li Lei |
| Correspondent | Li Lei Shenzhen Mindray Bio-Medical Electronics Co., LTD Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-15 |
| Decision Date | 2022-12-02 |