SIMPLE T NASAL MASK

Ventilator, Non-continuous (respirator)

RESPIRONICS INC.

The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Simple T Nasal Mask.

Pre-market Notification Details

Device IDK120145
510k NumberK120145
Device Name:SIMPLE T NASAL MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville,  PA  15668
ContactMichelle Brinker
CorrespondentMichelle Brinker
RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville,  PA  15668
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-18
Decision Date2012-03-30

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