The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for A Series And Q Series Patient Monitors.
| Device ID | K131898 |
| 510k Number | K131898 |
| Device Name: | A SERIES AND Q SERIES PATIENT MONITORS |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2014-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310218 | K131898 | 000 |
| 06932562310201 | K131898 | 000 |
| 06932562310195 | K131898 | 000 |
| 06932562310188 | K131898 | 000 |
| 06932562310171 | K131898 | 000 |
| 06932562310096 | K131898 | 000 |
| 06932562310089 | K131898 | 000 |
| B510PM200M1 | K131898 | 000 |