O-PEP
K号: K150044 · 2016-05-27
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决定日期2016-05-27
产品代码BWF
咨询委员会AN
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决定实质等同
器械摘要
O-PEP is the device name listed in this FDA 510(k) record. The listed applicant is Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2016-05-27 under 510(k) number K150044. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the O-PEP?
O-PEP is a medical device that received FDA 510(k) clearance on 2016-05-27. The listed applicant is Pari Respiratory Equipment, Inc.. The 510(k) number is K150044.
When did O-PEP receive FDA 510(k) clearance?
O-PEP received FDA 510(k) clearance on 2016-05-27, under 510(k) number K150044.
Who is the listed applicant for O-PEP?
The FDA 510(k) record lists Pari Respiratory Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for O-PEP?
The FDA product code for O-PEP is BWF.
列明Pari Respiratory Equipment, 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：BWF）
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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