HAPI 密封
K号: K162598 · 2017-05-23
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申请人Bisco, Inc.
决定日期2017-05-23
产品代码EBC
咨询委员会DE
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决定实质等同
器械摘要
HAPI Seal is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K162598. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HAPI Seal?
HAPI Seal is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Bisco, Inc.. The 510(k) number is K162598.
When did HAPI Seal receive FDA 510(k) clearance?
HAPI Seal received FDA 510(k) clearance on 2017-05-23, under 510(k) number K162598.
Who is the listed applicant for HAPI Seal?
The FDA 510(k) record lists Bisco, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HAPI Seal?
The FDA product code for HAPI Seal is EBC.
列明Bisco, 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：EBC）
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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