F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
K-Number: K173060 · 2018-01-25
ApplicantFisher and Paykel Healthcare Limited
Decision Date2018-01-25
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is a medical device manufactured by Fisher and Paykel Healthcare Limited. It received FDA 510(k) clearance on 2018-01-25 under approval number K173060. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is a medical device that received FDA 510(k) clearance on 2018-01-25. It is manufactured by Fisher and Paykel Healthcare Limited. The 510(k) number is K173060.
When was F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version approved by the FDA?
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version received FDA 510(k) clearance on 2018-01-25, under approval number K173060.
What company makes F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is manufactured by Fisher and Paykel Healthcare Limited.
What is the FDA product code for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?
The FDA product code for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is CBK.
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Official Source
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