FDA 510(k)

F&P Optiflow 鼻氧气管及二氧化碳采样

K号: K201723 · 2021-03-16

决定日期2021-03-16

产品代码BTT

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling 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 2021-03-16 under 510(k) number K201723. 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 Nasal Oxygen Cannula with CO2 Sampling?

F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling is a medical device that received FDA 510(k) clearance on 2021-03-16. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K201723.

When did F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling receive FDA 510(k) clearance?

F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling received FDA 510(k) clearance on 2021-03-16, under 510(k) number K201723.

Who is the listed applicant for F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling?

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 Nasal Oxygen Cannula with CO2 Sampling?

The FDA product code for F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling 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。

K253479Optiflow Switch+ 过滤鼻接口带CO2采样（AA042J）K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS)；OptiPAP Junior 鼻塞 XXS (OPTIPAPPXXS)；OptiPAP Junior 鼻塞 XS (OPTIPAPPXS)；OptiPAP Junior 鼻塞 S (OPTIPAPPS)；OptiPAP Junior 鼻塞 M (OPTIPAPPM)；OptiPAP Junior 鼻塞 L (OPTIPAPPL)；OptiPAP Junior 鼻塞 XL (OPTIPAPPXL)；OptiPAP Junior 鼻罩 XXS (OPTIPAPMXXS)；OptiPAP Junior 鼻罩 XS (OPTIPAPMXS)；OptiPAP Junior 鼻罩 S (OPTIPAPMS)；OptiPAP Junior 鼻罩 M (OPTIPAPMM)；OptiPAP Jun K252173F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸A (ONIV117A)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸B (ONIV117B)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸C (ONIV117C)；F&P OptiNIV ONIV117-F医院通气全脸面罩带可选呼气过滤器与单肢电路兼容 - 尺寸A (ONIV117A-F)；F&P OptiNIV ONIV117-F医院通气全脸面罩 K243917F&P Optiflow空气/氧气流量源 K251611Optiflow+ 鼻导管 - 小型（OPT942）；Optiflow+ 鼻导管 - 中型（OPT944）；Optiflow+ 鼻导管 - 大型（OPT946）；Optiflow+ 鼻导管小型（MYOPT9SMALL）；Optiflow+ 鼻导管中型（MYOPT9MEDIUM）；Optiflow+ 鼻导管大型（MYOPT9LARGE）K233643F&P Airvo 3 NIV (PT311US)

查看所有 25 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。