HAMILTON-C2

Ventilator, Continuous, Facility Use

HAMILTON MEDICAL AG

The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Hamilton-c2.

Pre-market Notification Details

Device IDK102775
510k NumberK102775
Device Name:HAMILTON-C2
ClassificationVentilator, Continuous, Facility Use
Applicant HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz,  CH Ch-7402
ContactJoerg Schneider
CorrespondentJoerg Schneider
HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz,  CH Ch-7402
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-24
Decision Date2011-01-21
Summary:summary

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