COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM— 510(k) K053304

Name: FDA 510(k) clearance K053304
Creator: U.S. Food and Drug Administration
Published: 2005-12-30

Substantially Equivalent

Cardiocom, LLC

FDA 510(k) clearance K053304 for COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM, Substantially Equivalent on 2005-12-30. Applicant: Cardiocom, LLC. Device class: 2.

Clearance details

Applicant: Cardiocom, LLC
Product code: Code DXN
Device class: Class 2
Regulation: 21 CFR 870.1130
Advisory panel: Cardiovascular
Date received: 2005-11-28
Decision date: 2005-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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K053303 — CARDIOCOM COMMANDER III2005-12-30

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.