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FDA 510(k)

21HK512D

K-Number: K191864 · 2019-12-05

ApplicantLg Electronics.Inc
Decision Date2019-12-05
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

21HK512D is the device name listed in this FDA 510(k) record. The listed applicant is Lg Electronics.Inc. It received FDA 510(k) clearance on 2019-12-05 under 510(k) number K191864. 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 21HK512D?

21HK512D is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Lg Electronics.Inc. The 510(k) number is K191864.

When did 21HK512D receive FDA 510(k) clearance?

21HK512D received FDA 510(k) clearance on 2019-12-05, under 510(k) number K191864.

Who is the listed applicant for 21HK512D?

The FDA 510(k) record lists Lg Electronics.Inc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 21HK512D?

The FDA product code for 21HK512D is PGY.

Other records listing Lg Electronics.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.

K261614LED LCD Monitor (OEV-271H)K261213Medical Monitor (40HT513D)K251209Medical Monitor (32HS710S)K243439Medical Monitor (27HS714S)K241402Medical Monitor (32HR734S)K233599X-Clever (ASHK100G)

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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

View on FDA Database →

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

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