MIRAGE FULL FACE MASK SERIES 2

Ventilator, Non-continuous (respirator)

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Mirage Full Face Mask Series 2.

Pre-market Notification Details

Device IDK023306
510k NumberK023306
Device Name:MIRAGE FULL FACE MASK SERIES 2
ClassificationVentilator, Non-continuous (respirator)
Applicant RESMED LTD. 14040 DANIELSON ST. Poway,  CA  92064 -6857
ContactRoger Kotter
CorrespondentRoger Kotter
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 Received2002-10-03
Decision Date2002-11-27
Summary:summary

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