Pylant 监测仪
K号: K191858 · 2020-02-24
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申请人Kal-Med, LLC
决定日期2020-02-24
产品代码BSK
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Pylant Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Kal-Med, LLC. It received FDA 510(k) clearance on 2020-02-24 under 510(k) number K191858. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pylant Monitor?
Pylant Monitor is a medical device that received FDA 510(k) clearance on 2020-02-24. The listed applicant is Kal-Med, LLC. The 510(k) number is K191858.
When did Pylant Monitor receive FDA 510(k) clearance?
Pylant Monitor received FDA 510(k) clearance on 2020-02-24, under 510(k) number K191858.
Who is the listed applicant for Pylant Monitor?
The FDA 510(k) record lists Kal-Med, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pylant Monitor?
The FDA product code for Pylant Monitor is BSK.
相关临床试验
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：BSK）
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。
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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