BELTBEAT WF-400— 510(k) K083715

Substantially Equivalent

Bonus Communicaciones Srl

FDA 510(k) clearance K083715 for BELTBEAT WF-400, Substantially Equivalent on 2009-09-15. Applicant: Bonus Communicaciones Srl.

Clearance details

Applicant: Bonus Communicaciones Srl
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2008-12-15
Decision date: 2009-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mizpe Aviv, IL

Download summary PDF View on FDA.gov ↗

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.