K951768

Substantially Equivalent

TEVES ECM PLUS THERMOCOUPLE

Applicant: Advanced Medical Concepts, Inc.
Product 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

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.