F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
K-Number: K191818 · 2020-03-19
ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2020-03-19
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2020-03-19 under approval number K191818. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)?
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) is a medical device that received FDA 510(k) clearance on 2020-03-19. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K191818.
When was F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) approved by the FDA?
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) received FDA 510(k) clearance on 2020-03-19, under approval number K191818.
What company makes F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)?
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) is manufactured by Fisher & Paykel Healthcare, Ltd..
What is the FDA product code for F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)?
The FDA product code for F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) is BTT.
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Official Source
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