K103493

Substantially Equivalent

HEAD FIATION DEVICE (HFD 100)

Applicant: Imris, Inc.
Product code: HBL
Advisory panel: Neurology
Date received: 2010-11-29
Decision date: 2011-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.