TEVES ECM PLUS THERMOCOUPLE— 510(k) K951768

Substantially Equivalent

Advanced Medical Concepts, Inc.

FDA 510(k) clearance K951768 for TEVES ECM PLUS THERMOCOUPLE, Substantially Equivalent on 1995-12-15. Applicant: Advanced Medical Concepts, Inc..

Clearance details

Applicant: Advanced Medical Concepts, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1995-04-17
Decision date: 1995-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brandenton, 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.