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FDA 510(k)

OptikView GUP2103CMI

K-Number: K191705 · 2020-03-16

ApplicantThe Linden Group Corp
Decision Date2020-03-16
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OptikView GUP2103CMI is the device name listed in this FDA 510(k) record. The listed applicant is The Linden Group Corp. It received FDA 510(k) clearance on 2020-03-16 under 510(k) number K191705. 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 OptikView GUP2103CMI?

OptikView GUP2103CMI is a medical device that received FDA 510(k) clearance on 2020-03-16. The listed applicant is The Linden Group Corp. The 510(k) number is K191705.

When did OptikView GUP2103CMI receive FDA 510(k) clearance?

OptikView GUP2103CMI received FDA 510(k) clearance on 2020-03-16, under 510(k) number K191705.

Who is the listed applicant for OptikView GUP2103CMI?

The FDA 510(k) record lists The Linden Group Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptikView GUP2103CMI?

The FDA product code for OptikView GUP2103CMI is PGY.

Other records listing The Linden Group Corp 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.

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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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