PAJUNK MULTISTIM SENSOR NERVE STIMULATORS— 510(k) K061172

Name: FDA 510(k) clearance K061172
Creator: U.S. Food and Drug Administration
Published: 2006-10-17

Substantially Equivalent

PAJUNK GmbH Medizintechnologie

FDA 510(k) clearance K061172 for PAJUNK MULTISTIM SENSOR NERVE STIMULATORS, Substantially Equivalent on 2006-10-17. Applicant: PAJUNK GmbH Medizintechnologie. Device class: 2.

Clearance details

Applicant: PAJUNK GmbH Medizintechnologie
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 2006-04-27
Decision date: 2006-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Dora, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BXN

product code BXN

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.