Patient Monitor
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
EDAN INSTRUMENTS, INC.
The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Patient Monitor.
Pre-market Notification Details
| Device ID | K152552 |
| 510k Number | K152552 |
| Device Name: | Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | EDAN INSTRUMENTS, INC. 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD 1019# Shenzhen, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Doug Worth EDAN MEDICAL 1200 CROSSMAN AVE. SUITE 200 Sunnyvale, CA 94086 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-08 |
| Decision Date | 2016-04-29 |
| Summary: | summary |
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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