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 | K112803 |
| 510k Number | K112803 |
| Device Name: | PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2011-10-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310102 | K112803 | 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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