K3
K号: K183347 · 2019-09-04
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决定日期2019-09-04
产品代码EIA
咨询委员会DE
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决定实质等同
器械摘要
K3 is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-09-04 under 510(k) number K183347. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the K3?
K3 is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K183347.
When did K3 receive FDA 510(k) clearance?
K3 received FDA 510(k) clearance on 2019-09-04, under 510(k) number K183347.
Who is the listed applicant for K3?
The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for K3?
The FDA product code for K3 is EIA.
列明Osstem Implant Co., Ltd.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：EIA）
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。
K251544牙科单元（MP2000-550LED-2.0，LP2100-550LED-2.0）Lakong Medical Devices Co., Ltd.K251626Midmark 牙科输送系统Midmark CorporationK251491K5 轮椅，K5 座位，K5 摆动Osstem Implant Company., Ltd. Chair BusinessK243130整体式牙科单元Guangdong Yadeng Medical Apparatus Co., Ltd.,K242611整体式牙科单元Mipont Medical Equipment Co., Ltd.K250473牙科输送系统系列5和牙科输送系统系列5 PlusDci International, LLC
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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