Cleared Special

Quantum Workstation 12.1

K181923 · Spectrum Medical , Ltd. · Cardiovascular
Aug 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K181923 is an FDA 510(k) clearance for the Quantum Workstation 12.1, 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 August 17, 2018, 30 days after receiving the submission on July 18, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4330.

Submission Details

510(k) Number K181923 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2018
Decision Date August 17, 2018
Days to Decision 30 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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