PATIENT MONITOR
Monitor, Physiological, Patient(with 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 | K102040 |
| 510k Number | K102040 |
| Device Name: | PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. 5D, NO. 19, LANE 999 ZHONGSHAN RD (S-2) Shanghai, CN 200030 |
| Contact | Ana Hong |
| Correspondent | Ana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD. 5D, NO. 19, LANE 999 ZHONGSHAN RD (S-2) Shanghai, CN 200030 |
| Product Code | MHX |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2010-09-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310119 | K102040 | 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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