K163283

Substantially Equivalent

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

Applicant: Hamilton Medical AG
Product code: BTT
Advisory panel: Anesthesiology
Date received: 2016-11-21
Decision date: 2017-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonaduz, CH

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.