Medical Monitor (40HT513D)— 510(k) K261213
Substantially EquivalentLg Electronics.Inc
FDA 510(k) clearance K261213 for Medical Monitor (40HT513D), Substantially Equivalent on 2026-06-12. Applicant: Lg Electronics.Inc. Device class: 2.
Summary
LG Electronics' Medical Monitor (40HT513D) is filed under PGY, diagnostic radiology displays. The record doesn't describe it beyond the model number and the code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
LG filed from Gumi-Si, South Korea. Review took 59 calendar days (April 14 to June 12, 2026).
Clearance details
- Applicant
- Lg Electronics.Inc
- Product code
- Product code PGY
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gumi-Si, KR
Recent devices under product code PGY
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