MYOGUIDE SYSTEM MODEL 8008— 510(k) K111985

Name: FDA 510(k) clearance K111985
Creator: U.S. Food and Drug Administration
Published: 2011-12-30

Substantially Equivalent

Intronix Technologies Corp.

FDA 510(k) clearance K111985 for MYOGUIDE SYSTEM MODEL 8008, Substantially Equivalent on 2011-12-30. Applicant: Intronix Technologies Corp.. Device class: 2.

Clearance details

Applicant: Intronix Technologies Corp.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 2011-07-12
Decision date: 2011-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.