HAZEL— 510(k) K912855

Substantially Equivalent

Kinetic Concepts, Inc.

FDA 510(k) clearance K912855 for HAZEL, Substantially Equivalent on 1991-09-06. Applicant: Kinetic Concepts, Inc..

Clearance details

Applicant: Kinetic Concepts, Inc.
Product code: Code IOQ
Advisory panel: Physical Medicine
Date received: 1991-06-28
Decision date: 1991-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.