K102856

Substantially Equivalent

SIROCCO THERMAL REGULATING SYSTEM

Applicant: Galmaz Biotech S.L.
Product code: DWJ
Advisory panel: Cardiovascular
Date received: 2010-09-29
Decision date: 2011-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, WI, US

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.