SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM

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 Freedom Wireless Fetal Monitoring System.

Pre-market Notification Details

Device IDK132650
510k NumberK132650
Device Name:SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
ClassificationSystem, Monitoring, Perinatal
Applicant HUNTLEIGH HEALTHCARE LIMITED 35 PORTMANMOOR ROAD Cardiff, Wales,  GB Cf24 5hn
ContactLaura Garcia Deacon
CorrespondentLaura Garcia Deacon
HUNTLEIGH HEALTHCARE LIMITED 35 PORTMANMOOR ROAD Cardiff, Wales,  GB Cf24 5hn
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-26
Decision Date2014-02-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05051968032416 K132650 000
05051968032409 K132650 000
05051968032133 K132650 000
05051968042057 K132650 000

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