SEJONG 外科手术服柔软型
K号: K220435 · 2023-02-10
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决定日期2023-02-10
产品代码FYA
咨询委员会SU
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决定实质等同
器械摘要
SEJONG Surgical Gown Soft is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K220435. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SEJONG Surgical Gown Soft?
SEJONG Surgical Gown Soft is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Sejong Healthcare Co., Ltd.. The 510(k) number is K220435.
When did SEJONG Surgical Gown Soft receive FDA 510(k) clearance?
SEJONG Surgical Gown Soft received FDA 510(k) clearance on 2023-02-10, under 510(k) number K220435.
Who is the listed applicant for SEJONG Surgical Gown Soft?
The FDA 510(k) record lists Sejong Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SEJONG Surgical Gown Soft?
The FDA product code for SEJONG Surgical Gown Soft is FYA.
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：FYA）
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
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