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FDA 510(k)

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

K-Number: K212031 · 2022-04-22

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2022-04-22
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K212031. 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 850 AirSpiral Adult NIV and NHF Circuit Kit?

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K212031.

When did F&P 850 AirSpiral Adult NIV and NHF Circuit Kit receive FDA 510(k) clearance?

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit received FDA 510(k) clearance on 2022-04-22, under 510(k) number K212031.

Who is the listed applicant for F&P 850 AirSpiral Adult NIV and NHF Circuit Kit?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F&P 850 AirSpiral Adult NIV and NHF Circuit Kit?

The FDA product code for F&P 850 AirSpiral Adult NIV and NHF Circuit Kit is BTT.

Other records listing Fisher & Paykel Healthcare, Ltd. as applicant

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Related Devices (Code: BTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LPK251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)Fisher & Paykel Healthcare, Ltd.

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.

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