ASPIRE Bellus II
K号: K171463 · 2017-09-29
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器械摘要
ASPIRE Bellus II is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K171463. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ASPIRE Bellus II?
ASPIRE Bellus II is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171463.
When did ASPIRE Bellus II receive FDA 510(k) clearance?
ASPIRE Bellus II received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171463.
Who is the listed applicant for ASPIRE Bellus II?
The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASPIRE Bellus II?
The FDA product code for ASPIRE Bellus II is LLZ.
相关临床试验
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列明Fujifilm Medical Systems U.S.A, Inc.为申报人的其他记录
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相关器械（代码：LLZ）
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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