The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Handheld Monitor.
| Device ID | K131762 |
| 510k Number | K131762 |
| Device Name: | HANDHELD MONITOR |
| 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 |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2014-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310362 | K131762 | 000 |