TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)— 510(k) K893609

Substantially Equivalent

Leonides Y. Teves, M.D., P.A.

FDA 510(k) clearance K893609 for TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR), Substantially Equivalent on 1989-10-30. Applicant: Leonides Y. Teves, M.D., P.A..

Clearance details

Applicant: Leonides Y. Teves, M.D., P.A.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1989-05-10
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bradenton, FL, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.