FDA 510(k)

SuperNO2VA 设备

K号: K163277 · 2017-10-13

决定日期2017-10-13

产品代码BSJ

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决定实质等同

器械摘要

SuperNO2VA Device is the device name listed in this FDA 510(k) record. The listed applicant is Revolutionary Medical Devices, Inc.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K163277. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SuperNO2VA Device?

SuperNO2VA Device is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Revolutionary Medical Devices, Inc.. The 510(k) number is K163277.

When did SuperNO2VA Device receive FDA 510(k) clearance?

SuperNO2VA Device received FDA 510(k) clearance on 2017-10-13, under 510(k) number K163277.

Who is the listed applicant for SuperNO2VA Device?

The FDA 510(k) record lists Revolutionary Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SuperNO2VA Device?

The FDA product code for SuperNO2VA Device is BSJ.

列明Revolutionary Medical Devices, 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。

K173147SuperNO2VA Et 设备

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。

器械摘要

常见问题

相关临床试验

列明Revolutionary Medical Devices, Inc.为申报人的其他记录

官方来源