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FDA 510(k)

Quantum Workstation

K-Number: K163657 · 2017-01-18

ApplicantSpectrum Medical , Ltd.
Decision Date2017-01-18
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Workstation 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 2017-01-18 under 510(k) number K163657. 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?

Quantum Workstation is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K163657.

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

Quantum Workstation received FDA 510(k) clearance on 2017-01-18, under 510(k) number K163657.

Who is the listed applicant for Quantum Workstation?

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?

The FDA product code for Quantum Workstation 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 ModuleK202557Quantum Workstation 12 EliteK192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

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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, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum 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.

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