MONORAIL— 510(k) K040143

Name: FDA 510(k) clearance K040143
Creator: U.S. Food and Drug Administration
Published: 2004-09-13

Substantially Equivalent

Nats Corp.

FDA 510(k) clearance K040143 for MONORAIL, Substantially Equivalent on 2004-09-13. Applicant: Nats Corp.. Device class: 2.

Clearance details

Applicant: Nats Corp.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2004-01-22
Decision date: 2004-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sound Beach, NY, US

Download summary PDF View on FDA.gov ↗

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K260006 — INOSS System2026-06-17

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Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.