510(k) K060781— MEDICAL COMPRESSOR, MODELS DK50 D AND DM

Substantially Equivalent

Ekom S.R.O.

Clearance details

Applicant: Ekom S.R.O.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 2006-03-22
Decision date: 2006-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dana Point, CA, 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.