MAINZ HEAD FIXATION BY PERNECZKY— 510(k) K901393

Substantially Equivalent

Zeppelin GmbH

FDA 510(k) clearance K901393 for MAINZ HEAD FIXATION BY PERNECZKY, Substantially Equivalent on 1990-09-04. Applicant: Zeppelin GmbH.

Clearance details

Applicant: Zeppelin GmbH
Product code: Code HBL
Advisory panel: Neurology
Date received: 1990-03-26
Decision date: 1990-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Germany, DE

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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.