OnGuard2 Chemfort Closed Administration (CADM)— 510(k) K210707

Substantially Equivalent

Simplivia Healthcare , Ltd.

FDA 510(k) clearance K210707 for OnGuard2 Chemfort Closed Administration (CADM), Substantially Equivalent on 2021-09-23. Applicant: Simplivia Healthcare , Ltd..

Clearance details

Applicant: Simplivia Healthcare , Ltd.
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2021-03-10
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kiryat Shmona, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code ONB

product code ONB

Malfunction: 3,615
Other: 13
Total: 3,628

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.