F&P Solo Mask Range
K-Number: K223696 · 2023-05-17
ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2023-05-17
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
F&P Solo Mask Range is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2023-05-17 under approval number K223696. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the F&P Solo Mask Range?
F&P Solo Mask Range is a medical device that received FDA 510(k) clearance on 2023-05-17. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K223696.
When was F&P Solo Mask Range approved by the FDA?
F&P Solo Mask Range received FDA 510(k) clearance on 2023-05-17, under approval number K223696.
What company makes F&P Solo Mask Range?
F&P Solo Mask Range is manufactured by Fisher & Paykel Healthcare, Ltd..
What is the FDA product code for F&P Solo Mask Range?
The FDA product code for F&P Solo Mask Range is BZD.
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Related Devices (Code: BZD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.