PRESSURE VALVE

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Pressure Valve.

Pre-market Notification Details

Device IDK963250
510k NumberK963250
Device Name:PRESSURE VALVE
ClassificationVentilator, Non-continuous (respirator)
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactFrancis Dobscha
CorrespondentFrancis Dobscha
RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-19
Decision Date1996-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30606959002563 K963250 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.