FDA 510(k)

Dell UP3216Q with QUBYX PerfectLum bundle

K号: K162196 · 2016-08-15

决定日期2016-08-15

产品代码PGY

咨询委员会RA

决定实质等同

器械摘要

Dell UP3216Q with QUBYX PerfectLum bundle is the device name listed in this FDA 510(k) record. The listed applicant is Qubyx Software Technologies, Inc.. It received FDA 510(k) clearance on 2016-08-15 under 510(k) number K162196. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dell UP3216Q with QUBYX PerfectLum bundle?

Dell UP3216Q with QUBYX PerfectLum bundle is a medical device that received FDA 510(k) clearance on 2016-08-15. The listed applicant is Qubyx Software Technologies, Inc.. The 510(k) number is K162196.

When did Dell UP3216Q with QUBYX PerfectLum bundle receive FDA 510(k) clearance?

Dell UP3216Q with QUBYX PerfectLum bundle received FDA 510(k) clearance on 2016-08-15, under 510(k) number K162196.

Who is the listed applicant for Dell UP3216Q with QUBYX PerfectLum bundle?

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

What is the FDA product code for Dell UP3216Q with QUBYX PerfectLum bundle?

The FDA product code for Dell UP3216Q with QUBYX PerfectLum bundle is PGY.

列明Qubyx Software Technologies, 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。

K171229DELL UP3017 with QUBYX PerfectLum bundle

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。