Cleared Traditional

Quantum Ventilation Module

K181942 · Spectrum Medical , Ltd. · Cardiovascular
Oct 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K181942 is an FDA 510(k) clearance for the Quantum Ventilation Module, a Gas Control Unit, Cardiopulmonary Bypass (Class II — Special Controls, product code DTX), submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on October 18, 2018, 90 days after receiving the submission on July 20, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4300.

Submission Details

510(k) Number K181942 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2018
Decision Date October 18, 2018
Days to Decision 90 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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