SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR

Monitor, Ultrasonic, Fetal

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Sonotrax Ultrasonic Fetal And Vascular Pocket Doppler, Models Lite, Basic, Pro, Ii, Ii Pro And Vascular.

Pre-market Notification Details

Device IDK080087
510k NumberK080087
Device Name:SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
ClassificationMonitor, Ultrasonic, Fetal
Applicant EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
ContactWilliam Stern
CorrespondentWilliam Stern
EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
Product CodeKNG  
CFR Regulation Number884.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-11
Decision Date2008-03-11
Summary:summary

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