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

Name: FDA 510(k) clearance K060781
Creator: U.S. Food and Drug Administration
Published: 2006-10-03

Substantially Equivalent

Ekom S.R.O.

FDA 510(k) clearance K060781 for MEDICAL COMPRESSOR, MODELS DK50 D AND DM, Substantially Equivalent on 2006-10-03. 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: 2006-03-22
Decision date: 2006-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dana Point, CA, US

Download summary PDF View on FDA.gov ↗

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K091871 — DK50 DS2009-10-23
K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES2008-11-19
K051691 — MINIMATE COMPRESSOR2005-12-09

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.