Central Monitoring System

System, Monitoring, Perinatal

Edan Instruments, Inc.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Central Monitoring System.

Pre-market Notification Details

Device IDK171178
510k NumberK171178
Device Name:Central Monitoring System
ClassificationSystem, Monitoring, Perinatal
Applicant Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Shenzhen,  CN 518122
ContactAlice Yang
CorrespondentDoug Worth
Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale,  CA  94089
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-21
Decision Date2017-09-06
Summary:summary

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