The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Central Monitoring System.
| Device ID | K170514 |
| 510k Number | K170514 |
| Device Name: | Central Monitoring System |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Guangdong Biolight Meditech Co., Ltd. No.2 Innovation First Road, Technical Innovation Coast, Hi-Tech Zone Zhuhai, CN 519085 |
| Contact | Jin Liang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.Box 120-119 Shanghai, CN 200120 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-05-24 |
| Summary: | summary |