ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000

Ventilator, Continuous, Facility Use

RESPIRONICS CALIFORNIA, INC.

The following data is part of a premarket notification filed by Respironics California, Inc. with the FDA for Esprit Ventilator Auto-trak Sensitivity Option, Model V1000.

Pre-market Notification Details

Device IDK072450
510k NumberK072450
Device Name:ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
ClassificationVentilator, Continuous, Facility Use
Applicant RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. Carlsbad,  CA  92011
ContactMara Caler
CorrespondentMara Caler
RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. Carlsbad,  CA  92011
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-31
Decision Date2007-12-12
Summary:summary

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