FRONT-LINE 场地灭菌器 (FL135)
K号: K243801 · 2025-03-07
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决定日期2025-03-07
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
FRONT-LINE Field Sterilizer (FL135) is the device name listed in this FDA 510(k) record. The listed applicant is Fort Defiance Industries, LLC. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K243801. 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 FRONT-LINE Field Sterilizer (FL135)?
FRONT-LINE Field Sterilizer (FL135) is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Fort Defiance Industries, LLC. The 510(k) number is K243801.
When did FRONT-LINE Field Sterilizer (FL135) receive FDA 510(k) clearance?
FRONT-LINE Field Sterilizer (FL135) received FDA 510(k) clearance on 2025-03-07, under 510(k) number K243801.
Who is the listed applicant for FRONT-LINE Field Sterilizer (FL135)?
The FDA 510(k) record lists Fort Defiance Industries, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FRONT-LINE Field Sterilizer (FL135)?
The FDA product code for FRONT-LINE Field Sterilizer (FL135) 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Fort Defiance Industries, LLC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。
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