H-H FIFTH VENTRICLE— 510(k) K853365

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K853365 for H-H FIFTH VENTRICLE, Substantially Equivalent on 1985-09-05. Applicant: Holter-Hausner Intl..

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code JXG
Advisory panel: Neurology
Date received: 1985-08-12
Decision date: 1985-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, PA, US

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.