NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX— 510(k) K031885

Substantially Equivalent

Image-Guided Neurologics, Inc.

FDA 510(k) clearance K031885 for NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX, Substantially Equivalent on 2003-08-21. Applicant: Image-Guided Neurologics, Inc..

Clearance details

Applicant: Image-Guided Neurologics, Inc.
Product code: Code HBL
Advisory panel: Neurology
Date received: 2003-06-18
Decision date: 2003-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

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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.