ADVENT VENTILATOR

Ventilator, Continuous, Facility Use

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Advent Ventilator.

Pre-market Notification Details

Device IDK884793
510k NumberK884793
Device Name:ADVENT VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant OHMEDA MEDICAL 9065 GUILFORD RD. Columbia,  MD  21046
ContactAlberto F Profumo
CorrespondentAlberto F Profumo
OHMEDA MEDICAL 9065 GUILFORD RD. Columbia,  MD  21046
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-16
Decision Date1989-06-12

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