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FDA 510(k)

Dell UP3216Q with QUBYX PerfectLum bundle

K-Number: K162196 · 2016-08-15

ApplicantQubyx Software Technologies, Inc.
Decision Date2016-08-15
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Qubyx Software Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171229DELL UP3017 with QUBYX PerfectLum bundle

Related Devices (Code: PGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo CorporationK243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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