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FDA 510(k)

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

K-Number: K192838 · 2020-04-13

ApplicantSpectrum Medical , Ltd.
Decision Date2020-04-13
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure 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 2020-04-13 under 510(k) number K192838. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is a medical device that received FDA 510(k) clearance on 2020-04-13. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K192838.

When did Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure receive FDA 510(k) clearance?

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure received FDA 510(k) clearance on 2020-04-13, under 510(k) number K192838.

Who is the listed applicant for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

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 Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

The FDA product code for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is DWA.

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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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