BRONCHOSCOPY ELBOW

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

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

Pre-market Notification Details

Device IDK132168
510k NumberK132168
Device Name:BRONCHOSCOPY ELBOW
ClassificationVentilator, Non-continuous (respirator)
Applicant RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh,  PA  15239
ContactColleen Witt
CorrespondentColleen Witt
RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh,  PA  15239
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-12
Decision Date2013-11-20

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