Patient Monitor
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Guangdong Biolight Meditech Co., Ltd.
The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Patient Monitor.
Pre-market Notification Details
| Device ID | K181919 |
| 510k Number | K181919 |
| Device Name: | Patient Monitor |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Guangdong Biolight Meditech Co., Ltd. No.2 Innovation First Road, Technology Innovation Coast, Hi-Tech Zone Zhuhai, CN 519085 |
| Contact | Dan Hou |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-18 |
| Decision Date | 2019-04-05 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310300 | K181919 | 000 |
Trademark Results [Patient Monitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |
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