DP-700 NIKMAN DEFIB-PADS— 510(k) K872793

Substantially Equivalent

Nikomed U.S.A., Inc.

FDA 510(k) clearance K872793 for DP-700 NIKMAN DEFIB-PADS, Substantially Equivalent on 1987-10-09. Applicant: Nikomed U.S.A., Inc..

Clearance details

Applicant: Nikomed U.S.A., Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1987-07-14
Decision date: 1987-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belle Mead, NJ, US

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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.