510(k) K211840— Sight OLO

Substantially Equivalent

S.D. Sight Diagnostics , Ltd.

Clearance details

Applicant: S.D. Sight Diagnostics , Ltd.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2021-06-14
Decision date: 2022-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

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.