ULTRA MIRAGE II MASK

Ventilator, Non-continuous (respirator)

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Ultra Mirage Ii Mask.

Pre-market Notification Details

Device IDK050359
510k NumberK050359
Device Name:ULTRA MIRAGE II MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant RESMED LTD. 14040 DANIELSON ST. Poway,  CA  92064 -6857
ContactDavid D'cruz
CorrespondentDavid D'cruz
RESMED LTD. 14040 DANIELSON ST. Poway,  CA  92064 -6857
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-14
Decision Date2005-03-16
Summary:summary

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