TALKING TRACH

Tube, Tracheostomy (w/wo Connector)

ENGINEERED MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Engineered Medical Systems, Inc. with the FDA for Talking Trach.

Pre-market Notification Details

Device IDK062104
510k NumberK062104
Device Name:TALKING TRACH
ClassificationTube, Tracheostomy (w/wo Connector)
Applicant ENGINEERED MEDICAL SYSTEMS, INC. 3460 POINTE CREEK # 102 Bonita Springs,  FL  34134 -2015
ContactPaul Dryden
CorrespondentPaul Dryden
ENGINEERED MEDICAL SYSTEMS, INC. 3460 POINTE CREEK # 102 Bonita Springs,  FL  34134 -2015
Product CodeBTO  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-24
Decision Date2007-04-20
Summary:summary

NIH GUDID Devices

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