EnFocus 2300，EnFocus 4400
K号: K162783 · 2016-12-09
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决定日期2016-12-09
产品代码OBO
咨询委员会OP
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决定实质等同
器械摘要
EnFocus 2300, EnFocus 4400 is the device name listed in this FDA 510(k) record. The listed applicant is Bioptigen, Inc.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K162783. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EnFocus 2300, EnFocus 4400?
EnFocus 2300, EnFocus 4400 is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Bioptigen, Inc.. The 510(k) number is K162783.
When did EnFocus 2300, EnFocus 4400 receive FDA 510(k) clearance?
EnFocus 2300, EnFocus 4400 received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162783.
Who is the listed applicant for EnFocus 2300, EnFocus 4400?
The FDA 510(k) record lists Bioptigen, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EnFocus 2300, EnFocus 4400?
The FDA product code for EnFocus 2300, EnFocus 4400 is OBO.
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相关器械（代码：OBO）
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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