MINIME PEDIATRIC MASK

Ventilator, Non-continuous (respirator)

SLEEPNET CORPORATION

The following data is part of a premarket notification filed by Sleepnet Corporation with the FDA for Minime Pediatric Mask.

Pre-market Notification Details

Device IDK090935
510k NumberK090935
Device Name:MINIME PEDIATRIC MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant SLEEPNET CORPORATION 24301 WOODSAGE DRIVE Bonita Springs,  FL  34134 -2958
ContactPaul Dryden
CorrespondentPaul Dryden
SLEEPNET CORPORATION 24301 WOODSAGE DRIVE Bonita Springs,  FL  34134 -2958
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-02
Decision Date2009-07-01
Summary:summary

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