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FDA 510(k)

Medical Monitor (40HT513D)

K-Number: K261213 · 2026-06-12

Decision Date2026-06-12
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Medical Monitor (40HT513D) 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 2026-06-12 under 510(k) number K261213. 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 Medical Monitor (40HT513D)?

Medical Monitor (40HT513D) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Lg Electronics.Inc. The 510(k) number is K261213.

When did Medical Monitor (40HT513D) receive FDA 510(k) clearance?

Medical Monitor (40HT513D) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261213.

Who is the listed applicant for Medical Monitor (40HT513D)?

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 Medical Monitor (40HT513D)?

The FDA product code for Medical Monitor (40HT513D) 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.

View all 32 devices →

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.

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.