蒸汽灭菌器 B 28 系列系列
K号: K151597 · 2016-03-04
广告
申请人Cefla S.C.
决定日期2016-03-04
产品代码FLE
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Family of Steam Sterilizers B 28 series is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K151597. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Family of Steam Sterilizers B 28 series?
Family of Steam Sterilizers B 28 series is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Cefla S.C.. The 510(k) number is K151597.
When did Family of Steam Sterilizers B 28 series receive FDA 510(k) clearance?
Family of Steam Sterilizers B 28 series received FDA 510(k) clearance on 2016-03-04, under 510(k) number K151597.
Who is the listed applicant for Family of Steam Sterilizers B 28 series?
The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Family of Steam Sterilizers B 28 series?
The FDA product code for Family of Steam Sterilizers B 28 series is FLE.
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Cefla S.C.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：FLE）
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。
K261055AMSCO 700 蒸汽灭菌器STERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N系列蒸汽灭菌器Maquet GmbH (A Getinge Group Company)K250168Life Ultra 25L 台式单室蒸汽灭菌器Lucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994蒸汽灭菌器 (2545D)Ningbo Ican Machines Co., Ltd.
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。
广告