ZIEHM VISION— 510(k) K011292

Substantially Equivalent

Ziehm International, Inc.

FDA 510(k) clearance K011292 for ZIEHM VISION, Substantially Equivalent on 2001-06-20. Applicant: Ziehm International, Inc..

Clearance details

Applicant: Ziehm International, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2001-04-30
Decision date: 2001-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

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Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.