CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM— 510(k) K020449

Name: FDA 510(k) clearance K020449
Creator: U.S. Food and Drug Administration
Published: 2002-05-10

Substantially Equivalent

Cardionow, Inc.

FDA 510(k) clearance K020449 for CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM, Substantially Equivalent on 2002-05-10. Applicant: Cardionow, Inc.. Device class: 2.

Clearance details

Applicant: Cardionow, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2002-02-11
Decision date: 2002-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Encinitas, CA, US

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K002597 — CN ACQUISITION STATION2000-11-17

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.