MODIFIED BETATRON IV INSULIN INFUSION SYSTEM— 510(k) K900498

Substantially Equivalent

Cardiac Pacemakers, Inc.

FDA 510(k) clearance K900498 for MODIFIED BETATRON IV INSULIN INFUSION SYSTEM, Substantially Equivalent on 1990-02-23. Applicant: Cardiac Pacemakers, Inc..

Clearance details

Applicant: Cardiac Pacemakers, Inc.
Product code: Code LZG
Advisory panel: General Hospital
Date received: 1990-01-18
Decision date: 1990-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.