Merits P335电动轮椅
K号: K220529 · 2022-03-18
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决定日期2022-03-18
产品代码ITI
咨询委员会PM
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决定实质等同
器械摘要
Merits P335 Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K220529. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Merits P335 Powered Wheelchair?
Merits P335 Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Merits Health Products Co., Ltd.. The 510(k) number is K220529.
When did Merits P335 Powered Wheelchair receive FDA 510(k) clearance?
Merits P335 Powered Wheelchair received FDA 510(k) clearance on 2022-03-18, under 510(k) number K220529.
Who is the listed applicant for Merits P335 Powered Wheelchair?
The FDA 510(k) record lists Merits Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Merits P335 Powered Wheelchair?
The FDA product code for Merits P335 Powered Wheelchair is ITI.
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。
相关器械（代码：ITI）
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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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。
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