Merits型号R106/R136康复轮椅
K号: K170517 · 2017-11-16
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决定日期2017-11-16
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
Merits Model R106/R136 Rehab Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Merits Healthcare Industries (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K170517. 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 Merits Model R106/R136 Rehab Wheelchair?
Merits Model R106/R136 Rehab Wheelchair is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Merits Healthcare Industries (Suzhou) Co., Ltd.. The 510(k) number is K170517.
When did Merits Model R106/R136 Rehab Wheelchair receive FDA 510(k) clearance?
Merits Model R106/R136 Rehab Wheelchair received FDA 510(k) clearance on 2017-11-16, under 510(k) number K170517.
Who is the listed applicant for Merits Model R106/R136 Rehab Wheelchair?
The FDA 510(k) record lists Merits Healthcare Industries (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Merits Model R106/R136 Rehab Wheelchair?
The FDA product code for Merits Model R106/R136 Rehab Wheelchair is IOR.
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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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