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FDA 510(k)

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

K-Number: K182744 · 2019-02-01

ApplicantEurotrol B.V.
Decision Date2019-02-01
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High is the device name listed in this FDA 510(k) record. The listed applicant is Eurotrol B.V.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K182744. The device is classified under product code GGM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High?

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Eurotrol B.V.. The 510(k) number is K182744.

When did HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High receive FDA 510(k) clearance?

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High received FDA 510(k) clearance on 2019-02-01, under 510(k) number K182744.

Who is the listed applicant for HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High?

The FDA 510(k) record lists Eurotrol B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High?

The FDA product code for HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High is GGM.

Other records listing Eurotrol B.V. 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.

K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighK152553CueSee Hypoxic

Related Devices (Code: GGM)

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.

K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V.

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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