TauTona 腹腔充气辅助装置（TPAD）
K号: K233020 · 2024-01-12
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决定日期2024-01-12
产品代码HIF
咨询委员会OB
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决定实质等同
器械摘要
TauTona Pneumoperitoneum Assist Device (TPAD) is the device name listed in this FDA 510(k) record. The listed applicant is Tautona Group Research & Development, Co., LLC. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233020. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TauTona Pneumoperitoneum Assist Device (TPAD)?
TauTona Pneumoperitoneum Assist Device (TPAD) is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Tautona Group Research & Development, Co., LLC. The 510(k) number is K233020.
When did TauTona Pneumoperitoneum Assist Device (TPAD) receive FDA 510(k) clearance?
TauTona Pneumoperitoneum Assist Device (TPAD) received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233020.
Who is the listed applicant for TauTona Pneumoperitoneum Assist Device (TPAD)?
The FDA 510(k) record lists Tautona Group Research & Development, Co., LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TauTona Pneumoperitoneum Assist Device (TPAD)?
The FDA product code for TauTona Pneumoperitoneum Assist Device (TPAD) is HIF.
相关临床试验
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相关器械（代码：HIF）
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。
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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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