Stimuplex Onvision System— 510(k) K192914

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K192914 for Stimuplex Onvision System, Substantially Equivalent on 2020-05-27. Applicant: Philips Medical Systems Nederland B.V..

Clearance details

Applicant: Philips Medical Systems Nederland B.V.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2019-10-15
Decision date: 2020-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Best, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.