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 IDK143695
510k NumberK143695
Device Name:CENTRAL MONITORING SYSTEM
ClassificationSystem, Monitoring, Perinatal
Applicant EDAN INSTRUMENTS INC 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK NANHAI RD 1019# Shenzhen,  CN 518067
ContactQueena Chen
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 Received2014-12-24
Decision Date2015-03-30
Summary:summary

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