手动轮椅 SIVFH2A102
K号: K190534 · 2019-05-29
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决定日期2019-05-29
产品代码IOR
咨询委员会PM
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决定实质等同
器械摘要
Manual Wheelchair SIVFH2A102 is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Horizon Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-29 under 510(k) number K190534. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Manual Wheelchair SIVFH2A102?
Manual Wheelchair SIVFH2A102 is a medical device that received FDA 510(k) clearance on 2019-05-29. The listed applicant is Jiangsu Horizon Medical Science & Technology Co., Ltd.. The 510(k) number is K190534.
When did Manual Wheelchair SIVFH2A102 receive FDA 510(k) clearance?
Manual Wheelchair SIVFH2A102 received FDA 510(k) clearance on 2019-05-29, under 510(k) number K190534.
Who is the listed applicant for Manual Wheelchair SIVFH2A102?
The FDA 510(k) record lists Jiangsu Horizon Medical Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Manual Wheelchair SIVFH2A102?
The FDA product code for Manual Wheelchair SIVFH2A102 is IOR.
相关临床试验
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相关器械（代码：IOR）
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
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