MICRO-PROCESSOR UNIT #A3600AC— 510(k) K801762

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K801762 for MICRO-PROCESSOR UNIT #A3600AC, Substantially Equivalent on 1980-08-27. Applicant: General Electric Co..

Clearance details

Applicant: General Electric Co.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1980-07-28
Decision date: 1980-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.