Green Card Bowie-Dick Test (BD115)
K号: K250172 · 2025-02-20
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决定日期2025-02-20
产品代码JOJ
咨询委员会医疗设备监管文本翻译如下：
HO
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器械摘要
Green Card Bowie-Dick Test (BD115) is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products, Inc. (A Getinge Company). It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K250172. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Green Card Bowie-Dick Test (BD115)?
Green Card Bowie-Dick Test (BD115) is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Steritec Products, Inc. (A Getinge Company). The 510(k) number is K250172.
When did Green Card Bowie-Dick Test (BD115) receive FDA 510(k) clearance?
Green Card Bowie-Dick Test (BD115) received FDA 510(k) clearance on 2025-02-20, under 510(k) number K250172.
Who is the listed applicant for Green Card Bowie-Dick Test (BD115)?
The FDA 510(k) record lists Steritec Products, Inc. (A Getinge Company) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Green Card Bowie-Dick Test (BD115)?
The FDA product code for Green Card Bowie-Dick Test (BD115) is JOJ.
相关临床试验
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相关器械（代码：JOJ）
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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