V-PRO® 1 Plus 和 V-PRO® maX 低温
K号: K160433 · 2016-07-06
广告
决定日期2016-07-06
产品代码MLR
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
V-PRO® 1 Plus and V-PRO® maX Low Temperature is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K160433. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the V-PRO® 1 Plus and V-PRO® maX Low Temperature?
V-PRO® 1 Plus and V-PRO® maX Low Temperature is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is STERIS Corporation. The 510(k) number is K160433.
When did V-PRO® 1 Plus and V-PRO® maX Low Temperature receive FDA 510(k) clearance?
V-PRO® 1 Plus and V-PRO® maX Low Temperature received FDA 510(k) clearance on 2016-07-06, under 510(k) number K160433.
Who is the listed applicant for V-PRO® 1 Plus and V-PRO® maX Low Temperature?
The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for V-PRO® 1 Plus and V-PRO® maX Low Temperature?
The FDA product code for V-PRO® 1 Plus and V-PRO® maX Low Temperature is MLR.
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STERIS Corporation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：MLR）
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。
K252843STERRAD 100NX 消毒系统，配备 ALLClear 技术（10104）Advanced Sterilization Products, Inc.K250802STERRAD® 100NX 消毒器，配备 ALLClear® 技术（10104）Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX 消毒器，配备 ALLClear® 技术和 ULTRA GI® 循环（10104）；APTIMAX® 仪器托盘，用于 ULTRA GI® 循环（011077）Advanced Sterilization ProductsK233762SteroScope® 灭菌技术系统Ideate Medical, Inc.K233065V-PRO maX 2 低温灭菌系统Steris
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