HAMILTON-C3

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-c3.

Pre-market Notification Details

Device IDK123637
510k NumberK123637
Device Name:HAMILTON-C3
ClassificationVentilator, Continuous, Facility Use
Applicant HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, Grisons,  CH 7402
ContactRalph Aguila
CorrespondentRalph Aguila
HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, Grisons,  CH 7402
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-26
Decision Date2012-12-21
Summary:summary

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