FETAL & MATERNAL MONITOR, MODEL F6, F9

System, Monitoring, Perinatal

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Fetal & Maternal Monitor, Model F6, F9.

Pre-market Notification Details

Device IDK082602
510k NumberK082602
Device Name:FETAL & MATERNAL MONITOR, MODEL F6, F9
ClassificationSystem, Monitoring, Perinatal
Applicant EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
ContactWilliam Stern
CorrespondentWilliam Stern
EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-08
Decision Date2008-11-26
Summary:summary

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