MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND— 510(k) K942072

Substantially Equivalent

Mabis Healthcare, Inc.

FDA 510(k) clearance K942072 for MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND, Substantially Equivalent on 1995-05-10. Applicant: Mabis Healthcare, Inc..

Clearance details

Applicant: Mabis Healthcare, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1994-04-29
Decision date: 1995-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.