AOCup 镜片盒带 AODisc
K号: K191795 · 2019-07-31
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决定日期2019-07-31
产品代码LPN
咨询委员会OP
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决定实质等同
器械摘要
AOCup Lens Case with AODisc is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K191795. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AOCup Lens Case with AODisc?
AOCup Lens Case with AODisc is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K191795.
When did AOCup Lens Case with AODisc receive FDA 510(k) clearance?
AOCup Lens Case with AODisc received FDA 510(k) clearance on 2019-07-31, under 510(k) number K191795.
Who is the listed applicant for AOCup Lens Case with AODisc?
The FDA 510(k) record lists Alcon Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AOCup Lens Case with AODisc?
The FDA product code for AOCup Lens Case with AODisc is LPN.
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。
列明Alcon Laboratories, 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。
K254052DAILIES TOTAL1®; DAILIES TOTAL1® 多焦点K252682LenSx 激光系统（8065000944）K243896LenSx 激光系统（8065998162）K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal ToricK242184Alcon 27GA Chandelier（8065000252）；Alcon 27+ DS广角内窥镜照明器（8065000253）；Alcon 27+ DS内窥镜照明器（8065000256）；K233876UNITY VCS（8065000296）；UNITY CS（8065000297）
相关器械（代码：LPN）
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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