FDA 510(k)

Vario 8/18/ci

K号: K153663 · 2016-05-18

决定日期2016-05-18

产品代码BTA

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决定实质等同

器械摘要

Vario 8/18/ci is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2016-05-18 under 510(k) number K153663. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vario 8/18/ci?

Vario 8/18/ci is a medical device that received FDA 510(k) clearance on 2016-05-18. The listed applicant is Medela AG. The 510(k) number is K153663.

When did Vario 8/18/ci receive FDA 510(k) clearance?

Vario 8/18/ci received FDA 510(k) clearance on 2016-05-18, under 510(k) number K153663.

Who is the listed applicant for Vario 8/18/ci?

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

What is the FDA product code for Vario 8/18/ci?

The FDA product code for Vario 8/18/ci is BTA.

列明Medela AG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：BTA）

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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