ZOOM-100DC— 510(k) K082886

Substantially Equivalent

Brainscope Company, Inc.

FDA 510(k) clearance K082886 for ZOOM-100DC, Substantially Equivalent on 2009-08-10. Applicant: Brainscope Company, Inc..

Clearance details

Applicant: Brainscope Company, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 2008-09-30
Decision date: 2009-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

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.