Cleared Traditional

SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G

K023745 · Sechrist Industries, Inc. · Cardiovascular
Jan 2003
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K023745 is an FDA 510(k) clearance for the SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G, a Gas Control Unit, Cardiopulmonary Bypass (Class II — Special Controls, product code DTX), submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on January 17, 2003, 71 days after receiving the submission on November 7, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4300.

Submission Details

510(k) Number K023745 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2002
Decision Date January 17, 2003
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTX — Gas Control Unit, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4300

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