LetsGetChecked Impress— 510(k) K242680

Unknown

Privapath Diagnostics Ltd (Dba Letsgetchecked)

FDA 510(k) clearance K242680 for LetsGetChecked Impress, Unknown on 2025-01-13. Applicant: Privapath Diagnostics Ltd (Dba Letsgetchecked).

Clearance details

Applicant: Privapath Diagnostics Ltd (Dba Letsgetchecked)
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2024-09-06
Decision date: 2025-01-13
Decision: Unknown
Clearance type: Traditional
Location: Dublin, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.