FDA 510(k)

VersaPAP 正压通气（PAP）设备

K号: K173918 · 2018-08-17

决定日期2018-08-17

产品代码BWF

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决定实质等同

器械摘要

VersaPAP Positive Airway Pressure (PAP) Device is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K173918. 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 VersaPAP Positive Airway Pressure (PAP) Device?

VersaPAP Positive Airway Pressure (PAP) Device is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Trudell Medical International. The 510(k) number is K173918.

When did VersaPAP Positive Airway Pressure (PAP) Device receive FDA 510(k) clearance?

VersaPAP Positive Airway Pressure (PAP) Device received FDA 510(k) clearance on 2018-08-17, under 510(k) number K173918.

Who is the listed applicant for VersaPAP Positive Airway Pressure (PAP) Device?

The FDA 510(k) record lists Trudell Medical International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VersaPAP Positive Airway Pressure (PAP) Device?

The FDA product code for VersaPAP Positive Airway Pressure (PAP) Device is BWF.

列明Trudell Medical International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。

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