SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G— 510(k) K023745

Substantially Equivalent

Sechrist Industries, Inc.

FDA 510(k) clearance K023745 for SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G, Substantially Equivalent on 2003-01-17. Applicant: Sechrist Industries, Inc..

Clearance details

Applicant: Sechrist Industries, Inc.
Product code: Code DTX
Advisory panel: Cardiovascular
Date received: 2002-11-07
Decision date: 2003-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

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Adverse events under product code DTX

product code DTX

Death: 3
Malfunction: 497
Total: 500

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.