HONEYWELL ELECTRONIC VENTILATOR EV-A

Ventilator, Continuous, Facility Use

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Honeywell Electronic Ventilator Ev-a.

Pre-market Notification Details

Device IDK853501
510k NumberK853501
Device Name:HONEYWELL ELECTRONIC VENTILATOR EV-A
ClassificationVentilator, Continuous, Facility Use
Applicant HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
ContactMartin Kutik
CorrespondentMartin Kutik
HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-20
Decision Date1986-04-04

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