Vital Signs Monitor:iM3s, IM3As, IM3Bs, IHM3s

Monitor, Physiological, Patient (without 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 Vital Signs Monitor:im3s, Im3as, Im3bs, Ihm3s.

Pre-market Notification Details

Device IDK202892
510k NumberK202892
Device Name:Vital Signs Monitor:iM3s, IM3As, IM3Bs, IHM3s
ClassificationMonitor, Physiological, Patient (without 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 CodeMWI  
Subsequent Product CodeDQA
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-01-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944413813465 K202892 000
06944413813458 K202892 000
06944413813441 K202892 000
06944413812055 K202892 000
06944413812048 K202892 000
06944413811874 K202892 000
06944413811171 K202892 000

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