VOLUME VENTILATOR

Ventilator, Continuous, Facility Use

SECHRIST INDUSTRIES, INC.

The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Volume Ventilator.

Pre-market Notification Details

Device IDK832508
510k NumberK832508
Device Name:VOLUME VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant SECHRIST INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-27
Decision Date1983-12-27

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