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 | K220058 |
510k Number | K220058 |
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 | 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 | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-06 |
Decision Date | 2022-06-01 |