TRACHEAL TUBE/STETHOSCOPE

Tube, Tracheal (w/wo Connector)

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Tracheal Tube/stethoscope.

Pre-market Notification Details

Device IDK842464
510k NumberK842464
Device Name:TRACHEAL TUBE/STETHOSCOPE
ClassificationTube, Tracheal (w/wo Connector)
Applicant MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-25
Decision Date1984-07-06

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