Sight OLO— 510(k) K190898

Substantially Equivalent

Sight Diagnostics , Ltd.

FDA 510(k) clearance K190898 for Sight OLO, Substantially Equivalent on 2019-11-01. Applicant: Sight Diagnostics , Ltd..

Clearance details

Applicant: Sight Diagnostics , Ltd.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2019-04-05
Decision date: 2019-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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.