Access CT
K号: K191136 · 2019-07-29
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器械摘要
Access CT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K191136. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Access CT?
Access CT is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K191136.
When did Access CT receive FDA 510(k) clearance?
Access CT received FDA 510(k) clearance on 2019-07-29, under 510(k) number K191136.
Who is the listed applicant for Access CT?
The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Access CT?
The FDA product code for Access CT is JAK.
相关临床试验
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列明Philips Healthcare (Suzhou) Co., 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。
相关器械（代码：JAK）
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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