VENTILATOR, PRESSURE

Ventilator, Continuous, Facility Use

THOMPSON RESPIRATION PRODUCTS, INC.

The following data is part of a premarket notification filed by Thompson Respiration Products, Inc. with the FDA for Ventilator, Pressure.

Pre-market Notification Details

Device IDK781159
510k NumberK781159
Device Name:VENTILATOR, PRESSURE
ClassificationVentilator, Continuous, Facility Use
Applicant THOMPSON RESPIRATION PRODUCTS, 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 Received1978-07-05
Decision Date1978-12-12

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