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 IDK201306
510k NumberK201306
Device Name:HAMILTON-C3
ClassificationVentilator, Continuous, Facility Use
Applicant Hamilton Medical AG Via Crusch 8 Bonaduz,  CH 7402
ContactSimone Haller
CorrespondentSimone Haller
Hamilton Medical AG Via Crusch 8 Bonaduz,  CH 7402
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-15
Decision Date2021-02-05

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