MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL)— 510(k) K862915

Substantially Equivalent

Neuromed, Inc.

FDA 510(k) clearance K862915 for MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL), Substantially Equivalent on 1986-10-06. Applicant: Neuromed, Inc..

Clearance details

Applicant: Neuromed, Inc.
Product code: Code GZB
Advisory panel: Neurology
Date received: 1986-08-01
Decision date: 1986-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davies, FL, US

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Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.