Cleared Special

Quantum Workstation

K163657 · Spectrum Medical , Ltd. · Cardiovascular
Jan 2017
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K163657 is an FDA 510(k) clearance for the Quantum Workstation, 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 January 18, 2017, 26 days after receiving the submission on December 23, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4330.

Submission Details

510(k) Number K163657 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2016
Decision Date January 18, 2017
Days to Decision 26 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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