FDA 510(k)

Astral 100/150

K号: K152068 · 2016-05-13

决定日期2016-05-13

产品代码CBK

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

Astral 100/150 is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K152068. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Astral 100/150?

Astral 100/150 is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Resmed, Ltd.. The 510(k) number is K152068.

When did Astral 100/150 receive FDA 510(k) clearance?

Astral 100/150 received FDA 510(k) clearance on 2016-05-13, under 510(k) number K152068.

Who is the listed applicant for Astral 100/150?

The FDA 510(k) record lists Resmed, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Astral 100/150?

The FDA product code for Astral 100/150 is CBK.

列明Resmed, Ltd.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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相关器械（代码：CBK）

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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