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 IDK110922
510k NumberK110922
Device Name:PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD1019 Shenzhen, Guangdong,  CN 518067
ContactRandy Jiang
CorrespondentRandy Jiang
EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD1019 Shenzhen, Guangdong,  CN 518067
Product CodeMHX  
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDSA
Subsequent Product CodeDSF
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-01
Decision Date2011-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944413807334 K110922 000
06944413800823 K110922 000
06944413800816 K110922 000

Trademark Results [PATIENT MONITOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PATIENT MONITOR
PATIENT MONITOR
74564296 1942340 Live/Registered
Brown, Frank L.
1994-08-22

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