ORCA (tm) - 操作性救援 containment 设备
K号: K163223 · 2017-11-02
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决定日期2017-11-02
产品代码LGM
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
ORCA (tm) - Operational Rescue Containment Apparatus is the device name listed in this FDA 510(k) record. The listed applicant is Isovac Products, LLC. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K163223. The device is classified under product code LGM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ORCA (tm) - Operational Rescue Containment Apparatus?
ORCA (tm) - Operational Rescue Containment Apparatus is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is Isovac Products, LLC. The 510(k) number is K163223.
When did ORCA (tm) - Operational Rescue Containment Apparatus receive FDA 510(k) clearance?
ORCA (tm) - Operational Rescue Containment Apparatus received FDA 510(k) clearance on 2017-11-02, under 510(k) number K163223.
Who is the listed applicant for ORCA (tm) - Operational Rescue Containment Apparatus?
The FDA 510(k) record lists Isovac Products, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ORCA (tm) - Operational Rescue Containment Apparatus?
The FDA product code for ORCA (tm) - Operational Rescue Containment Apparatus is LGM.
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：LGM）
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。
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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