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 | K162607 |
| 510k Number | K162607 |
| 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 | DRQ |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2017-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904093444 | K162607 | 000 |
| 06944904098364 | K162607 | 000 |
| 06944904098371 | K162607 | 000 |
| 06944904098388 | K162607 | 000 |
| 06944904098814 | K162607 | 000 |
| 06944904098821 | K162607 | 000 |
| 06944904040776 | K162607 | 000 |
| 06944904040783 | K162607 | 000 |
| 06944904040790 | K162607 | 000 |
| 06944904040806 | K162607 | 000 |
| 06944904086859 | K162607 | 000 |
| 06944904086866 | K162607 | 000 |
| 06944904086873 | K162607 | 000 |
| 06944904086880 | K162607 | 000 |
| 06936415900809 | K162607 | 000 |