Cleared Traditional

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas

K173591 · Spectrum Medical , Ltd. · Cardiovascular
Mar 2018
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K173591 is an FDA 510(k) clearance for the Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas, 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 March 28, 2018, 127 days after receiving the submission on November 21, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4330.

Submission Details

510(k) Number K173591 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2017
Decision Date March 28, 2018
Days to Decision 127 days
Submission Type Traditional
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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