CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR

System, Monitoring, Perinatal

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Cadence, Cadence Dual, Cadence Ii Fetal Monitor.

Pre-market Notification Details

Device IDK082369
510k NumberK082369
Device Name:CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-18
Decision Date2008-11-07
Summary:summary

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