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FDA 510(k)

Quantum Workstation 12.1

K-Number: K181923 · 2018-08-17

ApplicantSpectrum Medical , Ltd.
Decision Date2018-08-17
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Workstation 12.1 is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2018-08-17 under approval number K181923. 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 12.1?

Quantum Workstation 12.1 is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K181923.

When was Quantum Workstation 12.1 approved by the FDA?

Quantum Workstation 12.1 received FDA 510(k) clearance on 2018-08-17, under approval number K181923.

What company makes Quantum Workstation 12.1?

Quantum Workstation 12.1 is manufactured by Spectrum Medical , Ltd..

What is the FDA product code for Quantum Workstation 12.1?

The FDA product code for Quantum Workstation 12.1 is DRY.

Other Devices by Spectrum Medical , Ltd.

K163657Quantum Workstation K181942Quantum Ventilation Module K173834Quantum Pump Console K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) K202733Quantum Ventilation Module

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Related Devices (Code: DRY)

K163657Quantum WorkstationSpectrum Medical , Ltd. K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems Corporation K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd. K202557Quantum Workstation 12 EliteSpectrum Medical , Ltd. K202154B-CaptaLivanova Deutschland, GmbH K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation

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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