AirPhysio正压呼吸机（PEP）设备
K号: K203209 · 2021-01-15
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决定日期2021-01-15
产品代码BYI
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
AirPhysio Positive Expiratory Pressure (PEP) Device is the device name listed in this FDA 510(k) record. The listed applicant is Airphysio Pty, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203209. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AirPhysio Positive Expiratory Pressure (PEP) Device?
AirPhysio Positive Expiratory Pressure (PEP) Device is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Airphysio Pty, Ltd.. The 510(k) number is K203209.
When did AirPhysio Positive Expiratory Pressure (PEP) Device receive FDA 510(k) clearance?
AirPhysio Positive Expiratory Pressure (PEP) Device received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203209.
Who is the listed applicant for AirPhysio Positive Expiratory Pressure (PEP) Device?
The FDA 510(k) record lists Airphysio Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device?
The FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device is BYI.
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相关器械（代码：BYI）
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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