The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Truscope Ultra Patient Monitor.
| Device ID | K162234 |
| 510k Number | K162234 |
| Device Name: | Truscope Ultra Patient Monitor |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. INNOVATION FIRST ROAD TECHNOLOGY INNOVATION COAST Zhuhai,, CN 519085 |
| Contact | Jing Liang |
| Correspondent | Diana Hong MID-LINK CONSULTING CO.,LTD P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-09 |
| Decision Date | 2017-01-04 |