BLEASE700/900 SERIES VENTILATORS

Ventilator, Continuous, Facility Use

SPACELABS HEALTHCARE

The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Blease700/900 Series Ventilators.

Pre-market Notification Details

Device IDK112729
510k NumberK112729
Device Name:BLEASE700/900 SERIES VENTILATORS
ClassificationVentilator, Continuous, Facility Use
Applicant SPACELABS HEALTHCARE P.O. BOX 3018 Nederland,  CO  80466
ContactThomas Kroenke
CorrespondentThomas Kroenke
SPACELABS HEALTHCARE P.O. BOX 3018 Nederland,  CO  80466
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-20
Decision Date2012-06-11
Summary:summary

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