CellaVision DC-1，CellaVision DC-1 PPA
K号: K200595 · 2020-10-16
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决定日期2020-10-16
产品代码JOY
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
CellaVision DC-1, CellaVision DC-1 PPA is the device name listed in this FDA 510(k) record. The listed applicant is CellaVision AB. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K200595. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CellaVision DC-1, CellaVision DC-1 PPA?
CellaVision DC-1, CellaVision DC-1 PPA is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is CellaVision AB. The 510(k) number is K200595.
When did CellaVision DC-1, CellaVision DC-1 PPA receive FDA 510(k) clearance?
CellaVision DC-1, CellaVision DC-1 PPA received FDA 510(k) clearance on 2020-10-16, under 510(k) number K200595.
Who is the listed applicant for CellaVision DC-1, CellaVision DC-1 PPA?
The FDA 510(k) record lists CellaVision AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CellaVision DC-1, CellaVision DC-1 PPA?
The FDA product code for CellaVision DC-1, CellaVision DC-1 PPA is JOY.
相关临床试验
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列明CellaVision AB为申报人的其他记录
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相关器械（代码：JOY）
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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