Innova Nasal Non-Vented Mask

Ventilator, Non-continuous (respirator)

Sleepnet Corporation

The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Innova Nasal Non-vented Mask.

Pre-market Notification Details

Device IDK203601
510k NumberK203601
Device Name:Innova Nasal Non-Vented Mask
ClassificationVentilator, Non-continuous (respirator)
Applicant Sleepnet Corporation 5 Merrill Industrial Drive Hampton,  NH  03842
ContactJennifer Kennedy
CorrespondentPaul Dryden
Sleepnet Corporation % ProMedic, LLC 131 Bay Point Dr NE St. Petersburg,  FL  33704
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-09
Decision Date2021-04-30

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