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 | K113833 |
| 510k Number | K113833 |
| Device Name: | VITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-05-01 |
| Summary: | summary |