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FDA 510(k)

Spectra Optia Apheresis System

K-Number: K183081 · 2019-02-05

ApplicantTerumobct, Inc.
Decision Date2019-02-05
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

Spectra Optia Apheresis System is a medical device manufactured by Terumobct, Inc.. It received FDA 510(k) clearance on 2019-02-05 under approval number K183081. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectra Optia Apheresis System?

Spectra Optia Apheresis System is a medical device that received FDA 510(k) clearance on 2019-02-05. It is manufactured by Terumobct, Inc.. The 510(k) number is K183081.

When was Spectra Optia Apheresis System approved by the FDA?

Spectra Optia Apheresis System received FDA 510(k) clearance on 2019-02-05, under approval number K183081.

What company makes Spectra Optia Apheresis System?

Spectra Optia Apheresis System is manufactured by Terumobct, Inc..

What is the FDA product code for Spectra Optia Apheresis System?

The FDA product code for Spectra Optia Apheresis System is LKN.

Related Clinical Trials

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Other Devices by Terumobct, Inc.

K153601Spectra Optia Apheresis System K162365T-Cuff K181049Spectra Optia Apheresis System K172590Spectra Optia Apheresis System

Related Devices (Code: LKN)

K153601Spectra Optia Apheresis SystemTerumobct, Inc. K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,Llc K181049Spectra Optia Apheresis SystemTerumobct, Inc. K172590Spectra Optia Apheresis SystemTerumobct, Inc. K192150AMICUS Separator SystemFresenius Kabi AG

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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