VEOLAR VENTILATOR

Ventilator, Continuous, Facility Use

HAMILTON MEDICAL, INC.

The following data is part of a premarket notification filed by Hamilton Medical, Inc. with the FDA for Veolar Ventilator.

Pre-market Notification Details

Device IDK901448
510k NumberK901448
Device Name:VEOLAR VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant HAMILTON MEDICAL, INC. P.O. BOX 30008 Reno,  NV  89520
ContactTim Cowart
CorrespondentTim Cowart
HAMILTON MEDICAL, INC. P.O. BOX 30008 Reno,  NV  89520
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-28
Decision Date1991-12-20

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