K935861

Substantially Equivalent

MEDNEXT BUR

Applicant: Mednext, Inc.
Product code: HBE
Advisory panel: Neurology
Date received: 1993-12-03
Decision date: 1994-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Point Beach, FL, US

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.