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FDA 510(k)

CueSee Hypoxic

K-Number: K152553 · 2016-04-22

ApplicantEurotrol B.V.
Decision Date2016-04-22
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CueSee Hypoxic 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 2016-04-22 under 510(k) number K152553. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CueSee Hypoxic?

CueSee Hypoxic is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Eurotrol B.V.. The 510(k) number is K152553.

When did CueSee Hypoxic receive FDA 510(k) clearance?

CueSee Hypoxic received FDA 510(k) clearance on 2016-04-22, under 510(k) number K152553.

Who is the listed applicant for CueSee Hypoxic?

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 CueSee Hypoxic?

The FDA product code for CueSee Hypoxic is JJS.

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 HighK182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

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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