IBM 5885 DIGITAL ECG ACQUISITION CART— 510(k) K810988

Substantially Equivalent

Intl. Business Machines

FDA 510(k) clearance K810988 for IBM 5885 DIGITAL ECG ACQUISITION CART, Substantially Equivalent on 1981-05-01. Applicant: Intl. Business Machines.

Clearance details

Applicant: Intl. Business Machines
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1981-04-13
Decision date: 1981-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.