DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

Device, Monitoring, Intracranial Pressure

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Directlink Icp Module, Directlink Icp Extension Cable, Patient Monitor Interface Cables.

Pre-market Notification Details

Device IDK152670
510k NumberK152670
Device Name:DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant Medos International SARL Chemin-Blanc 38 Le Locle,  CH Ch-2400
ContactElena Jugo
CorrespondentElena Jugo
Medos International SARL Chemin-Blanc 38 Le Locle,  CH Ch-2400
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-17
Decision Date2016-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780520801 K152670 000
10381780515784 K152670 000
10381780520610 K152670 000
10381780520719 K152670 000
10381780520726 K152670 000
10381780520733 K152670 000
10381780520740 K152670 000
10381780520757 K152670 000
10381780520788 K152670 000
10381780520795 K152670 000
10381780538349 K152670 000

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