MONITOR ONE NDX— 510(k) K972991

Name: FDA 510(k) clearance K972991
Creator: U.S. Food and Drug Administration
Published: 1998-12-03

Substantially Equivalent

Qmed, Inc.

FDA 510(k) clearance K972991 for MONITOR ONE NDX, Substantially Equivalent on 1998-12-03. Applicant: Qmed, Inc.. Device class: 2.

Clearance details

Applicant: Qmed, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1997-08-12
Decision date: 1998-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sag Harbor, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.