HEAD FIATION DEVICE (HFD 100)— 510(k) K103493

Substantially Equivalent

Imris, Inc.

FDA 510(k) clearance K103493 for HEAD FIATION DEVICE (HFD 100), Substantially Equivalent on 2011-03-11. Applicant: Imris, Inc..

Clearance details

Applicant: Imris, Inc.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.