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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 a medical device manufactured by Eurotrol B.V.. It received FDA 510(k) clearance on 2016-04-22 under approval 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. It is manufactured by Eurotrol B.V.. The 510(k) number is K152553.

When was CueSee Hypoxic approved by the FDA?

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

What company makes CueSee Hypoxic?

CueSee Hypoxic is manufactured by Eurotrol B.V..

What is the FDA product code for CueSee Hypoxic?

The FDA product code for CueSee Hypoxic is JJS.

Other Devices by Eurotrol 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.