MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR

Ventilator, Continuous, Facility Use

SIEMENS ELEMA AB

The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Master Program Flow & Pressure Co2 & Lung Monitor.

Pre-market Notification Details

Device IDK861707
510k NumberK861707
Device Name:MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR
ClassificationVentilator, Continuous, Facility Use
Applicant SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg,  IL  60195
ContactChrister Hellsten
CorrespondentChrister Hellsten
SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg,  IL  60195
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-05
Decision Date1986-06-19

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