VITAL SIGNS MONITOR

Oximeter

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Vital Signs Monitor.

Pre-market Notification Details

Device IDK083821
510k NumberK083821
Device Name:VITAL SIGNS MONITOR
ClassificationOximeter
Applicant EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
ContactWilliam Stern
CorrespondentWilliam Stern
EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-22
Decision Date2009-05-14
Summary:summary

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