SIMPLE T YOUTH 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 Youth Nasal Mask.

Pre-market Notification Details

Device IDK140268
510k NumberK140268
Device Name:SIMPLE T YOUTH NASAL MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactColleen Witt
CorrespondentColleen Witt
RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-12
Decision Date2014-10-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00606959040007 K140268 000
00606959039995 K140268 000
00606959039988 K140268 000
00606959039971 K140268 000

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