HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE— 510(k) K871135

Substantially Equivalent

First Medical Devices Corp.

FDA 510(k) clearance K871135 for HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE, Substantially Equivalent on 1987-05-12. Applicant: First Medical Devices Corp..

Clearance details

Applicant: First Medical Devices Corp.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1987-03-20
Decision date: 1987-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, 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.