FDA applicant
Dr. Lee Co., Ltd.
FDA records 2 decisions for Dr. Lee Co., Ltd. (Irvine, CA) in 1998: 2 510(k) clearances. Most are in product codes LOS (Unnamed device) and DPS (Electrocardiograph). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dr. Lee Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dr. Lee Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dr. Lee Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report