OTC DDR
K号: K221853 · 2022-07-27
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器械摘要
OTC DDR is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta Healthcare Americas, Inc.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K221853. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OTC DDR?
OTC DDR is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Konica Minolta Healthcare Americas, Inc.. The 510(k) number is K221853.
When did OTC DDR receive FDA 510(k) clearance?
OTC DDR received FDA 510(k) clearance on 2022-07-27, under 510(k) number K221853.
Who is the listed applicant for OTC DDR?
The FDA 510(k) record lists Konica Minolta Healthcare Americas, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OTC DDR?
The FDA product code for OTC DDR is KPR.
列明Konica Minolta Healthcare Americas, Inc.为申报人的其他记录
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：KPR）
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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