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FDA 510(k)

Quantum Workstation

K-Number: K163657 · 2017-01-18

Decision Date2017-01-18
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Workstation is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2017-01-18 under approval 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. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K163657.

When was Quantum Workstation approved by the FDA?

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

What company makes Quantum Workstation?

Quantum Workstation is manufactured by Spectrum Medical , Ltd..

What is the FDA product code for Quantum Workstation?

The FDA product code for Quantum Workstation is DRY.

Other Devices by Spectrum Medical , Ltd.

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Related Devices (Code: DRY)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.