Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum

System, Monitoring, Perinatal

Huntleigh Healthcare Limited

The following data is part of a premarket notification filed by Huntleigh Healthcare Limited with the FDA for Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum.

Pre-market Notification Details

Device IDK200975
510k NumberK200975
Device Name:Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
ClassificationSystem, Monitoring, Perinatal
Applicant Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff,  GB Cf24 5hn
ContactSteve Monks
CorrespondentSteve Monks
Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff,  GB Cf24 5hn
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-13
Decision Date2020-06-24

NIH GUDID Devices

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