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FDA 510(k)

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas

K-Number: K173591 · 2018-03-28

ApplicantSpectrum Medical , Ltd.
Decision Date2018-03-28
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2018-03-28 under approval number K173591. 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 Diagnostic Module, Quantum Diagnostic Module - No Gas?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is a medical device that received FDA 510(k) clearance on 2018-03-28. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K173591.

When was Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas approved by the FDA?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas received FDA 510(k) clearance on 2018-03-28, under approval number K173591.

What company makes Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is manufactured by Spectrum Medical , Ltd..

What is the FDA product code for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

The FDA product code for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas 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.

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