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

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..

Clearance details

Applicant: Cardionow, Inc.
Product code: Code LLZ
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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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.