CARDIOMET 4000 GAS MONITORING SYSTEMS— 510(k) K862069

Substantially Equivalent

Biomedical Sensors, Inc.

FDA 510(k) clearance K862069 for CARDIOMET 4000 GAS MONITORING SYSTEMS, Substantially Equivalent on 1986-07-18. Applicant: Biomedical Sensors, Inc..

Clearance details

Applicant: Biomedical Sensors, Inc.
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1986-05-30
Decision date: 1986-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buckinghamshire, England, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.