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FDA 510(k)

氯化钠吸入溶液，3%，3.5%，7%和10%

K号: K210126 · 2021-12-03

申请人The Ritedose Corporation
决定日期2021-12-03
产品代码CAF
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

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is the device name listed in this FDA 510(k) record. The listed applicant is The Ritedose Corporation. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K210126. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is The Ritedose Corporation. The 510(k) number is K210126.

When did Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% receive FDA 510(k) clearance?

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% received FDA 510(k) clearance on 2021-12-03, under 510(k) number K210126.

Who is the listed applicant for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

The FDA 510(k) record lists The Ritedose Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

The FDA product code for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is CAF.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：CAF）

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。

K254171网状雾化器（UN204）；网状雾化器（UN205）；网状雾化器（UN209）；网状雾化器（UN210）Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE 用于 pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid带eTrack系统Pari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035便携式网状雾化器（JM821）Shenzhen Jermei Medical Device Technology Co., Ltd.K243468压缩机雾化器（NB-1100）；压缩机雾化器（NB-1101）；压缩机雾化器（NB-1102）；压缩机雾化器（NB-1103）Joytech Healthcare Co. , Ltd.

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