PeriCALM Patterns 3.0
K号: K241009 · 2025-01-10
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决定日期2025-01-10
产品代码HGM
咨询委员会OB
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决定实质等同
器械摘要
PeriCALM Patterns 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Perigen, Inc.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K241009. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PeriCALM Patterns 3.0?
PeriCALM Patterns 3.0 is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Perigen, Inc.. The 510(k) number is K241009.
When did PeriCALM Patterns 3.0 receive FDA 510(k) clearance?
PeriCALM Patterns 3.0 received FDA 510(k) clearance on 2025-01-10, under 510(k) number K241009.
Who is the listed applicant for PeriCALM Patterns 3.0?
The FDA 510(k) record lists Perigen, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PeriCALM Patterns 3.0?
The FDA product code for PeriCALM Patterns 3.0 is HGM.
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：HGM）
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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