Sunset Heated CPAP Tube

Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

Sunset Healthcare Solutions, Inc.

The following data is part of a premarket notification filed by Sunset Healthcare Solutions, Inc. with the FDA for Sunset Heated Cpap Tube.

Pre-market Notification Details

Device IDK201418
510k NumberK201418
Device Name:Sunset Heated CPAP Tube
ClassificationHeater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Applicant Sunset Healthcare Solutions, Inc. 180 N. Michigan Ave, Suite 2000 Chicago,  IL  60601
ContactN. (nazree) Williams
CorrespondentThomas Kroenke
Speed To Market, Inc. 2235 East Flamingo Road, Suite 201G Las Vegas,  NV  89119
Product CodeBZE  
CFR Regulation Number868.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-29
Decision Date2021-01-29

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