FDA 510(k)

ArchFlo CT 中线

K号: K171483 · 2017-12-15

申请人Medcomp (Dba Medical Components, Inc.)

决定日期2017-12-15

产品代码PND

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决定实质等同

器械摘要

ArchFlo CT Midline is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Dba Medical Components, Inc.). It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K171483. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ArchFlo CT Midline?

ArchFlo CT Midline is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Medcomp (Dba Medical Components, Inc.). The 510(k) number is K171483.

When did ArchFlo CT Midline receive FDA 510(k) clearance?

ArchFlo CT Midline received FDA 510(k) clearance on 2017-12-15, under 510(k) number K171483.

Who is the listed applicant for ArchFlo CT Midline?

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

What is the FDA product code for ArchFlo CT Midline?

The FDA product code for ArchFlo CT Midline is PND.

列明Medcomp (Dba Medical Components, 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。

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官方来源

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