Ventilator, Non-continuous (Respirator)

Ventilator, Non-continuous (respirator)

Respironics, Inc.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Ventilator, Non-continuous (respirator).

Pre-market Notification Details

Device IDK201439
510k NumberK201439
Device Name:Ventilator, Non-continuous (Respirator)
ClassificationVentilator, Non-continuous (respirator)
Applicant Respironics, Inc. 1001 Murry Ridge Lane Murrysville,  PA  15668
ContactJennifer Richardson
CorrespondentJennifer Richardson
Respironics, Inc. 1001 Murry Ridge Lane Murrysville,  PA  15668
Product CodeBZD  
Subsequent Product CodeCAW
Subsequent Product CodeCBK
Subsequent Product CodeMNR
Subsequent Product CodeMNS
Subsequent Product CodeMNT
Subsequent Product CodeNOU
Subsequent Product CodeOLZ
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2020-09-25

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