LOWTEM Crystal 120— 510(k) K231893

Substantially Equivalent

Lowtem Co., Ltd.

FDA 510(k) clearance K231893 for LOWTEM Crystal 120, Substantially Equivalent on 2024-09-18. Applicant: Lowtem Co., Ltd..

Clearance details

Applicant: Lowtem Co., Ltd.
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2023-06-28
Decision date: 2024-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MLR

product code MLR

Malfunction: 805
Total: 805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.