OnSite Waste Sharps Container
K号: K182235 · 2019-05-20
广告
决定日期2019-05-20
产品代码MMK
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
OnSite Waste Sharps Container is the device name listed in this FDA 510(k) record. The listed applicant is Bluestone Medical, Inc.. It received FDA 510(k) clearance on 2019-05-20 under 510(k) number K182235. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OnSite Waste Sharps Container?
OnSite Waste Sharps Container is a medical device that received FDA 510(k) clearance on 2019-05-20. The listed applicant is Bluestone Medical, Inc.. The 510(k) number is K182235.
When did OnSite Waste Sharps Container receive FDA 510(k) clearance?
OnSite Waste Sharps Container received FDA 510(k) clearance on 2019-05-20, under 510(k) number K182235.
Who is the listed applicant for OnSite Waste Sharps Container?
The FDA 510(k) record lists Bluestone Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OnSite Waste Sharps Container?
The FDA product code for OnSite Waste Sharps Container is MMK.
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。
相关器械（代码：MMK）
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。
K260845华宏锐器容器（HHR-I，HHR-II）Tianjin Huahong Technology Co., Ltd.K253773冠红锐器容器（GHW-1F1）；冠红锐器容器（GHW-1F4）；冠红锐器容器（GH-6FA）；冠红锐器容器（GHW-2FR）；冠红锐器容器（GHW-8FR）；冠红锐器容器（GH-3FS）；冠红锐器容器（GHW-15FS）；冠红锐器容器（GHW-27FS）；冠红锐器容器（GH-5FSW）；冠红锐器容器（GHW-3FT）；冠红锐器容器（GHW-4FT）；冠红锐器容器（GHW-5FT）；冠红锐器容器（GHW-8FT）；冠红Taizhou Huangyan Guanhong Plastic Steel Products FactoryK253222公洞锐器容器（SCR-01Q，SCR-01G，SCR-03G）Zhejiang Gongdong Medical Technology Co., Ltd.K252637社区容器（翻盖和雏菊）Keter Canada, Inc.K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc.K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc.
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