TAP 3, TAP 1

Sleep Appliances With Patient Monitoring

Airway Management, Inc.

The following data is part of a premarket notification filed by Airway Management, Inc. with the FDA for Tap 3, Tap 1.

Pre-market Notification Details

Device IDK160239
510k NumberK160239
Device Name:TAP 3, TAP 1
ClassificationSleep Appliances With Patient Monitoring
Applicant Airway Management, Inc. 3418 Midcourt Road, Ste. 114 Carrollton,  TX  75006
ContactDale Siebenmorgen
CorrespondentPaul Dryden
ProMedic, Inc. 24301 Woodsage Drive Bonita Springs,  FL  34134
Product CodePLC  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-01
Decision Date2016-08-10
Summary:summary

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