NEBULIZER ACCESSORY FOR SERVO VENTILL

Nebulizer (direct Patient Interface)

SIEMENS ELEMA AB

The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Nebulizer Accessory For Servo Ventill.

Pre-market Notification Details

Device IDK832898
510k NumberK832898
Device Name:NEBULIZER ACCESSORY FOR SERVO VENTILL
ClassificationNebulizer (direct Patient Interface)
Applicant SIEMENS ELEMA AB 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-26
Decision Date1983-11-25

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