CARE 5000 SYSTEM— 510(k) K894858

Substantially Equivalent

Care Systems, Inc.

FDA 510(k) clearance K894858 for CARE 5000 SYSTEM, Substantially Equivalent on 1989-10-12. Applicant: Care Systems, Inc..

Clearance details

Applicant: Care Systems, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1989-07-31
Decision date: 1989-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntsville, AL, US

Download summary PDF View on FDA.gov ↗

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.