MONITOR ONE NDX— 510(k) K972991

Substantially Equivalent

Qmed, Inc.

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

Clearance details

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

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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.