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 | K153580 |
| 510k Number | K153580 |
| Device Name: | Central Monitoring System |
| Classification | System, Monitoring, Perinatal |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. NO. 2 INNOVATION FIRST ROAD TECHNOLOGY 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 200237 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-15 |
| Decision Date | 2016-09-07 |
| Summary: | summary |