FDA 510(k)

XSTAT-12，3件套，XSTAT-12，1件套

K号: K161020 · 2016-07-28

决定日期2016-07-28

产品代码PGZ

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决定实质等同

器械摘要

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is the device name listed in this FDA 510(k) record. The listed applicant is Revmedx, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161020. The device is classified under product code PGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Revmedx, Inc.. The 510(k) number is K161020.

When did XSTAT-12, 3-Pack, XSTAT-12, 1-Pack receive FDA 510(k) clearance?

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161020.

Who is the listed applicant for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

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

What is the FDA product code for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

The FDA product code for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is PGZ.

列明Revmedx, 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。

K253290XSTAT P15 K210676XSTAT 30 袋 K180051XSTAT 30，1件装 K170334XSTAT 30，3件套；XSTAT 30，1件套；XSTAT 12，3件套；XSTAT 12，1件套

官方来源

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