FDA 510(k)

SANDMAN ELITE

K号: K153353 · 2016-06-23

决定日期2016-06-23

产品代码OLZ

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决定实质等同

器械摘要

SANDMAN ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153353. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SANDMAN ELITE?

SANDMAN ELITE is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Embla Systems. The 510(k) number is K153353.

When did SANDMAN ELITE receive FDA 510(k) clearance?

SANDMAN ELITE received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153353.

Who is the listed applicant for SANDMAN ELITE?

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

What is the FDA product code for SANDMAN ELITE?

The FDA product code for SANDMAN ELITE is OLZ.

列明Embla Systems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。

K180001一次性成人呼吸传感器，一次性小型成人/儿童呼吸传感器，一次性早产儿呼吸传感器，一次性婴儿呼吸传感器 K173793XactTrace 单次使用呼吸努力带系统 K172703一次性快接电极 K163617REMbrandt K162140RemLogic

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