FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)— 510(k) K041644

Substantially Equivalent

Elekon Industries U.S.A., Inc.

FDA 510(k) clearance K041644 for FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE), Substantially Equivalent on 2004-07-29. Applicant: Elekon Industries U.S.A., Inc..

Clearance details

Applicant: Elekon Industries U.S.A., Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2004-06-17
Decision date: 2004-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.