FDA 510(k)

F&P Optiflow Junior 2/2+ 鼻导管接口范围

K号: K222197 · 2023-04-06

决定日期2023-04-06

产品代码BTT

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决定实质等同

器械摘要

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range 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 2023-04-06 under 510(k) number K222197. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range?

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K222197.

When did F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range receive FDA 510(k) clearance?

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range received FDA 510(k) clearance on 2023-04-06, under 510(k) number K222197.

Who is the listed applicant for F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range?

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 Optiflow Junior 2/2+ Nasal Cannula Interface Range?

The FDA product code for F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range is BTT.

列明Fisher & Paykel Healthcare, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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