MEDNEXT BUR— 510(k) K935584

Name: FDA 510(k) clearance K935584
Creator: U.S. Food and Drug Administration
Published: 1994-02-22

Substantially Equivalent

Mednext, Inc.

FDA 510(k) clearance K935584 for MEDNEXT BUR, Substantially Equivalent on 1994-02-22. Applicant: Mednext, Inc.. Device class: 1.

Clearance details

Applicant: Mednext, Inc.
Product code: Code EQJ
Device class: Class 1
Regulation: 21 CFR 874.4140
Advisory panel: Ear, Nose, Throat
Date received: 1993-11-18
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Point Beach, FL, US

Download summary PDF View on FDA.gov ↗

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K935861 — MEDNEXT BUR1994-05-03

Adverse events under product code EQJ

product code EQJ

Malfunction: 1,552
Total: 1,552

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.