IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2— 510(k) K812355

Substantially Equivalent

Intl. Business Machines

FDA 510(k) clearance K812355 for IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2, Substantially Equivalent on 1981-09-09. Applicant: Intl. Business Machines.

Clearance details

Applicant: Intl. Business Machines
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1981-08-19
Decision date: 1981-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.