F&P InfoSmart
K-Number: K161686 · 2017-01-24
ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2017-01-24
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
F&P InfoSmart is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2017-01-24 under approval number K161686. 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 InfoSmart?
F&P InfoSmart is a medical device that received FDA 510(k) clearance on 2017-01-24. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K161686.
When was F&P InfoSmart approved by the FDA?
F&P InfoSmart received FDA 510(k) clearance on 2017-01-24, under approval number K161686.
What company makes F&P InfoSmart?
F&P InfoSmart is manufactured by Fisher & Paykel Healthcare, Ltd..
What is the FDA product code for F&P InfoSmart?
The FDA product code for F&P InfoSmart 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.