The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Benevision Central Monitoring System.
| Device ID | K183238 |
| 510k Number | K183238 |
| Device Name: | BeneVision Central Monitoring System |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Contact | Yanhong Bai |
| Correspondent | Yanhong Bai Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Product Code | MSX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DXN |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904093437 | K183238 | 000 |
| 06944904093420 | K183238 | 000 |
| 06944904093413 | K183238 | 000 |