TRACOE Smart Cuff Manager

Cuff, Tracheal Tube, Inflatable

TRACOE MEDICAL GMBH

The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracoe Smart Cuff Manager.

Pre-market Notification Details

Device IDK152865
510k NumberK152865
Device Name:TRACOE Smart Cuff Manager
ClassificationCuff, Tracheal Tube, Inflatable
Applicant TRACOE MEDICAL GMBH REICHELSHEIMER STR. 1/3 Nieder-olm,  DE D-55268
ContactStephan Kohler
CorrespondentEva Schaeffer
TRACOE MEDICAL GMBH REICHELSHEIMER STR. 1/3 55268 Nieder-olm,  DE D-55268
Product CodeBSK  
CFR Regulation Number868.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-30
Decision Date2016-09-27
Summary:summary

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