SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000— 510(k) K011729

Name: FDA 510(k) clearance K011729
Creator: U.S. Food and Drug Administration
Published: 2001-08-30

Substantially Equivalent

Dni Nevada, Inc.

FDA 510(k) clearance K011729 for SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000, Substantially Equivalent on 2001-08-30. Applicant: Dni Nevada, Inc.. Device class: 2.

Clearance details

Applicant: Dni Nevada, Inc.
Product code: Code DTC
Device class: Class 2
Regulation: 21 CFR 870.3630
Advisory panel: Cardiovascular
Date received: 2001-06-04
Decision date: 2001-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carson City, NV, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.