The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Vital Signs Monitor.
| Device ID | K153135 |
| 510k Number | K153135 |
| Device Name: | VITAL SIGNS 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 | Jin Liang |
| Correspondent | Diana Hong MID-LINK CONSLTING 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 | 2015-10-30 |
| Decision Date | 2016-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310126 | K153135 | 000 |
| 00616784084114 | K153135 | 000 |
| 00616784084015 | K153135 | 000 |