510(k) K023354— COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E

Substantially Equivalent

Siemens Elema AB

Clearance details

Applicant: Siemens Elema AB
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 2002-10-07
Decision date: 2003-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.