FDA 510(k)

21HK512D

K-Number: K191864 · 2019-12-05

Decision Date2019-12-05

Product CodePGY

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

21HK512D is a medical device manufactured by Lg Electronics.Inc. It received FDA 510(k) clearance on 2019-12-05 under approval 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. It is manufactured by Lg Electronics.Inc. The 510(k) number is K191864.

When was 21HK512D approved by the FDA?

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

What company makes 21HK512D?

21HK512D is manufactured by Lg Electronics.Inc.

What is the FDA product code for 21HK512D?

The FDA product code for 21HK512D is PGY.

Other Devices by Lg Electronics.Inc

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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.