Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) 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. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K202557.

When did Quantum Workstation 12 Elite receive FDA 510(k) clearance?

Quantum Workstation 12 Elite received FDA 510(k) clearance on 2020-10-02, under 510(k) number K202557.

Who is the listed applicant for Quantum Workstation 12 Elite?

The FDA 510(k) record lists Spectrum Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Workstation 12 Elite?

The FDA product code for Quantum Workstation 12 Elite is DRY.

Other records listing Spectrum Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)K212657Quantum Heater-CoolerK210669Quantum Mini Ventilation ModuleK202733Quantum Ventilation ModuleK192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

View all 12 devices →

Related Devices (Code: DRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.K163657Quantum WorkstationSpectrum Medical , Ltd.

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.

↑