ACCUHEART ELECTRODE BELT— 510(k) K043361

Substantially Equivalent

Advanced Bioelectric Corporation

FDA 510(k) clearance K043361 for ACCUHEART ELECTRODE BELT, Substantially Equivalent on 2005-03-22. Applicant: Advanced Bioelectric Corporation.

Clearance details

Applicant: Advanced Bioelectric Corporation
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2004-12-07
Decision date: 2005-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, Qc, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.