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FDA 510(k)

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

K-Number: K192842 · 2019-11-15

ApplicantEurotrol B.V.
Decision Date2019-11-15
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo 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 2019-11-15 under 510(k) number K192842. 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 Duo Low, HemoTrol Duo Normal, HemoTrol Duo High?

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Eurotrol B.V.. The 510(k) number is K192842.

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

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192842.

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

The FDA product code for HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo 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.

K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - 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.

K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V.

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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