HELIOS 785 Pico
K号: K230373 · 2023-05-22
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决定日期2023-05-22
产品代码GEX
咨询委员会SU
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决定实质等同
器械摘要
HELIOS 785 Pico is the device name listed in this FDA 510(k) record. The listed applicant is Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K230373. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the HELIOS 785 Pico?
HELIOS 785 Pico is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K230373.
When did HELIOS 785 Pico receive FDA 510(k) clearance?
HELIOS 785 Pico received FDA 510(k) clearance on 2023-05-22, under 510(k) number K230373.
Who is the listed applicant for HELIOS 785 Pico?
The FDA 510(k) record lists Laseroptek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HELIOS 785 Pico?
The FDA product code for HELIOS 785 Pico is GEX. This falls under the Gastroenterology category.
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。
列明Laseroptek Co., Ltd.为申报人的其他记录
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：GEX）
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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