Cleared Special

Quantum Workstation 12 Elite

K202557 · Spectrum Medical , Ltd. · Cardiovascular
Oct 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K202557 is an FDA 510(k) clearance for the Quantum Workstation 12 Elite, a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II — Special Controls, product code DRY), submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on October 2, 2020, 29 days after receiving the submission on September 3, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4330.

Submission Details

510(k) Number K202557 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2020
Decision Date October 02, 2020
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRY — Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4330

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