K914971

Substantially Equivalent

TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION

Applicant: Nihon Kohden America, Inc.
Product code: LDD
Advisory panel: Cardiovascular
Date received: 1991-10-18
Decision date: 1991-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.