RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM

Ventilator, External Body, Negative Pressure, Adult (cuirass)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Vacuvest Respiratory Support System.

Pre-market Notification Details

Device IDK895849
510k NumberK895849
Device Name:RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
ClassificationVentilator, External Body, Negative Pressure, Adult (cuirass)
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactEugene N Scarberry
CorrespondentEugene N Scarberry
RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeBYT  
CFR Regulation Number868.5935 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-03
Decision Date1989-12-22

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