SERIES 1500 RESPONDER— 510(k) K902782

Substantially Equivalent

Marquette Electronics, Inc.

FDA 510(k) clearance K902782 for SERIES 1500 RESPONDER, Substantially Equivalent on 1991-01-18. Applicant: Marquette Electronics, Inc..

Clearance details

Applicant: Marquette Electronics, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1990-06-26
Decision date: 1991-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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.