Quantum Workstation 12 Elite
K-Number: K202557 · 2020-10-02
ApplicantSpectrum Medical , Ltd.
Decision Date2020-10-02
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Quantum Workstation 12 Elite is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2020-10-02 under approval number K202557. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quantum Workstation 12 Elite?
Quantum Workstation 12 Elite is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K202557.
When was Quantum Workstation 12 Elite approved by the FDA?
Quantum Workstation 12 Elite received FDA 510(k) clearance on 2020-10-02, under approval number K202557.
What company makes Quantum Workstation 12 Elite?
Quantum Workstation 12 Elite is manufactured by Spectrum Medical , Ltd..
What is the FDA product code for Quantum Workstation 12 Elite?
The FDA product code for Quantum Workstation 12 Elite is DRY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.