IVENT 201 PORTABLE VENTILATOR

Ventilator, Continuous, Facility Use

VERSAMED MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Versamed Medical Systems, Inc. with the FDA for Ivent 201 Portable Ventilator.

Pre-market Notification Details

Device IDK042468
510k NumberK042468
Device Name:IVENT 201 PORTABLE VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant VERSAMED MEDICAL SYSTEMS, INC. 2 BLUE HILL PLAZA BLDG. 2, 3RD FLOOR Pearl River,  NY  10965
ContactJerry Korten
CorrespondentJerry Korten
VERSAMED MEDICAL SYSTEMS, INC. 2 BLUE HILL PLAZA BLDG. 2, 3RD FLOOR Pearl River,  NY  10965
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-13
Decision Date2004-11-17
Summary:summary

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