MIRARI® 冷等离子体系统 (GV-M2-01)
K号: K242553 · 2024-11-21
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决定日期2024-11-21
产品代码PBX
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
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器械摘要
MIRARI® Cold Plasma System ( GV-M2-01) is the device name listed in this FDA 510(k) record. The listed applicant is General Vibronics, Inc.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K242553. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MIRARI® Cold Plasma System ( GV-M2-01)?
MIRARI® Cold Plasma System ( GV-M2-01) is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is General Vibronics, Inc.. The 510(k) number is K242553.
When did MIRARI® Cold Plasma System ( GV-M2-01) receive FDA 510(k) clearance?
MIRARI® Cold Plasma System ( GV-M2-01) received FDA 510(k) clearance on 2024-11-21, under 510(k) number K242553.
Who is the listed applicant for MIRARI® Cold Plasma System ( GV-M2-01)?
The FDA 510(k) record lists General Vibronics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MIRARI® Cold Plasma System ( GV-M2-01)?
The FDA product code for MIRARI® Cold Plasma System ( GV-M2-01) is PBX.
相关临床试验
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相关器械（代码：PBX）
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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