PEACH 2, PEACH 2 Duo, PEACH 2 go
K号: K231977 · 2023-09-25
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器械摘要
PEACH 2, PEACH 2 Duo, PEACH 2 go is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K231977. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PEACH 2, PEACH 2 Duo, PEACH 2 go?
PEACH 2, PEACH 2 Duo, PEACH 2 go is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Foreo, Inc.. The 510(k) number is K231977.
When did PEACH 2, PEACH 2 Duo, PEACH 2 go receive FDA 510(k) clearance?
PEACH 2, PEACH 2 Duo, PEACH 2 go received FDA 510(k) clearance on 2023-09-25, under 510(k) number K231977.
Who is the listed applicant for PEACH 2, PEACH 2 Duo, PEACH 2 go?
The FDA 510(k) record lists Foreo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PEACH 2, PEACH 2 Duo, PEACH 2 go?
The FDA product code for PEACH 2, PEACH 2 Duo, PEACH 2 go is OHT.
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Foreo, Inc.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：OHT）
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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