PIXI PEDIATRIC MASK

Ventilator, Non-continuous (respirator)

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Pixi Pediatric Mask.

Pre-market Notification Details

Device IDK102224
510k NumberK102224
Device Name:PIXI PEDIATRIC MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego,  CA  92123
ContactDavid D'cruz
CorrespondentDavid D'cruz
RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego,  CA  92123
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-06
Decision Date2010-12-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.