SKIA-Head（型号：SKIA-ST00）
K号: K253486 · 2026-02-23
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器械摘要
SKIA-Head (Model: SKIA-ST00) is the device name listed in this FDA 510(k) record. The listed applicant is Skia, Inc.. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K253486. 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 SKIA-Head (Model: SKIA-ST00)?
SKIA-Head (Model: SKIA-ST00) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Skia, Inc.. The 510(k) number is K253486.
When did SKIA-Head (Model: SKIA-ST00) receive FDA 510(k) clearance?
SKIA-Head (Model: SKIA-ST00) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253486.
Who is the listed applicant for SKIA-Head (Model: SKIA-ST00)?
The FDA 510(k) record lists Skia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SKIA-Head (Model: SKIA-ST00)?
The FDA product code for SKIA-Head (Model: SKIA-ST00) is LLZ.
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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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