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FDA 510(k)

Spectra Optia Apheresis System

K-Number: K181049 · 2018-11-01

ApplicantTerumobct, Inc.
Decision Date2018-11-01
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

Spectra Optia Apheresis System is the device name listed in this FDA 510(k) record. The listed applicant is Terumobct, Inc.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K181049. 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 2018-11-01. The listed applicant is Terumobct, Inc.. The 510(k) number is K181049.

When did Spectra Optia Apheresis System receive FDA 510(k) clearance?

Spectra Optia Apheresis System received FDA 510(k) clearance on 2018-11-01, under 510(k) number K181049.

Who is the listed applicant for Spectra Optia Apheresis System?

The FDA 510(k) record lists Terumobct, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Terumobct, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183081Spectra Optia Apheresis SystemK172590Spectra Optia Apheresis SystemK162365T-CuffK153601Spectra Optia Apheresis System

Related Devices (Code: LKN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192150AMICUS Separator SystemFresenius Kabi AGK183081Spectra 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,LlcK172590Spectra Optia Apheresis SystemTerumobct, Inc.K153601Spectra Optia Apheresis SystemTerumobct, Inc.

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.

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