D668 & D664 CENTRAL MONITORING SYSTEMS— 510(k) K800243

Substantially Equivalent

Medtel Pty. , Ltd.

FDA 510(k) clearance K800243 for D668 & D664 CENTRAL MONITORING SYSTEMS, Substantially Equivalent on 1980-04-10. Applicant: Medtel Pty. , Ltd..

Clearance details

Applicant: Medtel Pty. , Ltd.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1980-02-05
Decision date: 1980-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.