SpectraWAVE Imaging System
K号: K221257 · 2023-02-28
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器械摘要
SpectraWAVE Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K221257. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SpectraWAVE Imaging System?
SpectraWAVE Imaging System is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Spectrawave, Inc.. The 510(k) number is K221257.
When did SpectraWAVE Imaging System receive FDA 510(k) clearance?
SpectraWAVE Imaging System received FDA 510(k) clearance on 2023-02-28, under 510(k) number K221257.
Who is the listed applicant for SpectraWAVE Imaging System?
The FDA 510(k) record lists Spectrawave, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SpectraWAVE Imaging System?
The FDA product code for SpectraWAVE Imaging System is NQQ.
相关临床试验
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。
列明Spectrawave, Inc.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：NQQ）
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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