FDA 510(k)

デル UP3216Q と QUBYX PerfectLum バンドル

K番号: K162196 · 2016-08-15

決定日2016-08-15

製品コードPGY

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてQubyx Software Technologies, Inc.を記載するその他の記録

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公式ソース

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