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 IDK202336
510k NumberK202336
Device Name:Patient Monitor
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
ContactAlice Yang
CorrespondentAlice Yang
Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
Product CodeMHX  
Subsequent Product CodeBZQ
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDPS
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDSI
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeMLD
Subsequent Product CodeNHO
Subsequent Product CodeNHP
Subsequent Product CodeNHQ
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-17
Decision Date2021-01-23

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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