Bunkerhill MAC
K号: K250662 · 2025-10-03
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器械摘要
Bunkerhill MAC is the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K250662. 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 Bunkerhill MAC?
Bunkerhill MAC is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is BunkerHill Health. The 510(k) number is K250662.
When did Bunkerhill MAC receive FDA 510(k) clearance?
Bunkerhill MAC received FDA 510(k) clearance on 2025-10-03, under 510(k) number K250662.
Who is the listed applicant for Bunkerhill MAC?
The FDA 510(k) record lists BunkerHill Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bunkerhill MAC?
The FDA product code for Bunkerhill MAC is JAK.
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列明BunkerHill Health为申报人的其他记录
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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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