COBE PATIENT MONITORING PRODUCTS— 510(k) K921343

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K921343 for COBE PATIENT MONITORING PRODUCTS, Substantially Equivalent on 1993-01-05. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1992-03-19
Decision date: 1993-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

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Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.