GLOW800
K号: K181537 · 2018-09-07
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器械摘要
GLOW800 is the device name listed in this FDA 510(k) record. The listed applicant is Leica Microsystems (Schweiz) AG. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181537. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GLOW800?
GLOW800 is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Leica Microsystems (Schweiz) AG. The 510(k) number is K181537.
When did GLOW800 receive FDA 510(k) clearance?
GLOW800 received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181537.
Who is the listed applicant for GLOW800?
The FDA 510(k) record lists Leica Microsystems (Schweiz) AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GLOW800?
The FDA product code for GLOW800 is IZI.
列明Leica Microsystems (Schweiz) AG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：IZI）
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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