MAGNUM 800(TM) MANAGEMENT SYSTEM— 510(k) K881844

Substantially Equivalent

The Medical Group, Inc.

FDA 510(k) clearance K881844 for MAGNUM 800(TM) MANAGEMENT SYSTEM, Substantially Equivalent on 1988-07-14. Applicant: The Medical Group, Inc..

Clearance details

Applicant: The Medical Group, Inc.
Product code: Code FNL
Advisory panel: General Hospital
Date received: 1988-05-02
Decision date: 1988-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buena Park, CA, US

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Adverse events under product code FNL

product code FNL

Death: 64
Injury: 728
Malfunction: 10,825
Other: 9
Total: 11,626

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.