MYOTEST NERVE STIMULATOR— 510(k) K823583

Name: FDA 510(k) clearance K823583
Creator: U.S. Food and Drug Administration
Published: 1982-12-30

Substantially Equivalent

Prothia USA, Inc.

FDA 510(k) clearance K823583 for MYOTEST NERVE STIMULATOR, Substantially Equivalent on 1982-12-30. Applicant: Prothia USA, Inc.. Device class: 2.

Clearance details

Applicant: Prothia USA, Inc.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 1982-12-06
Decision date: 1982-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.