DK50 DS— 510(k) K091871

Name: FDA 510(k) clearance K091871
Creator: U.S. Food and Drug Administration
Published: 2009-10-23

Substantially Equivalent

Ekom S.R.O.

FDA 510(k) clearance K091871 for DK50 DS, Substantially Equivalent on 2009-10-23. Applicant: Ekom S.R.O.. Device class: 2.

Clearance details

Applicant: Ekom S.R.O.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 2009-06-23
Decision date: 2009-10-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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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.