Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

Mixer, Breathing Gases, Anesthesia Inhalation

Parker Hannifin

The following data is part of a premarket notification filed by Parker Hannifin with the FDA for Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50.

Pre-market Notification Details

Device IDK202480
510k NumberK202480
Device Name:Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
ClassificationMixer, Breathing Gases, Anesthesia Inhalation
Applicant Parker Hannifin 245 Township Line Road Hatfield,  PA  19440
ContactAndrew Ellinger
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeBZR  
CFR Regulation Number868.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-28
Decision Date2021-04-22

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