TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

System, Monitoring, Perinatal

TENACORE HOLDINGS, INC.

The following data is part of a premarket notification filed by Tenacore Holdings, Inc. with the FDA for Tenacore Transducers For Fetal Ultrasonic And Tokodynamometer Monitoring.

Pre-market Notification Details

Device IDK043075
510k NumberK043075
Device Name:TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
ClassificationSystem, Monitoring, Perinatal
Applicant TENACORE HOLDINGS, INC. 647 EAST YOUNG STREET Santa Ana,  CA  92705
ContactBrand Caso
CorrespondentBrand Caso
TENACORE HOLDINGS, INC. 647 EAST YOUNG STREET Santa Ana,  CA  92705
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-08
Decision Date2005-08-18
Summary:summary

NIH GUDID Devices

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