ORG-8200A UNIVERSAL SIGNAL HOUSING— 510(k) K912744

Substantially Equivalent

Nihon Kohden America, Inc.

FDA 510(k) clearance K912744 for ORG-8200A UNIVERSAL SIGNAL HOUSING, Substantially Equivalent on 1991-12-09. Applicant: Nihon Kohden America, Inc..

Clearance details

Applicant: Nihon Kohden America, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1991-06-21
Decision date: 1991-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.