MYOTRACK, MODEL HH 515— 510(k) K904025

Name: FDA 510(k) clearance K904025
Creator: U.S. Food and Drug Administration
Published: 1991-03-01

Substantially Equivalent

Myotrack Co.

FDA 510(k) clearance K904025 for MYOTRACK, MODEL HH 515, Substantially Equivalent on 1991-03-01. Applicant: Myotrack Co.. Device class: 2.

Clearance details

Applicant: Myotrack Co.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 1990-08-30
Decision date: 1991-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

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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.