Patient Monitor: RespArray

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: Resparray.

Pre-market Notification Details

Device IDK220308
510k NumberK220308
Device Name:Patient Monitor: RespArray
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
ContactJoan. Wei
CorrespondentJoan. Wei
Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
Product CodeMHX  
Subsequent Product CodeCCK
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDSB
Subsequent Product CodeDSI
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 Received2022-02-02
Decision Date2022-08-11

NIH GUDID Devices

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