MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1— 510(k) K043380

Substantially Equivalent

Monebo Technologies, Inc.

FDA 510(k) clearance K043380 for MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1, Substantially Equivalent on 2005-04-26. Applicant: Monebo Technologies, Inc..

Clearance details

Applicant: Monebo Technologies, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2004-12-08
Decision date: 2005-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.