Cleared Special

Quantum Ventilation Module

K202733 · Spectrum Medical , Ltd. · Cardiovascular
Oct 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K202733 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 16, 2020, 28 days after receiving the submission on September 18, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4300.

Submission Details

510(k) Number K202733 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2020
Decision Date October 16, 2020
Days to Decision 28 days
Submission Type Special
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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