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FDA 510(k)

AnemoCheck

K-Number: K163215 · 2017-09-13

ApplicantSanguina, LLC
Decision Date2017-09-13
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AnemoCheck is a medical device manufactured by Sanguina, LLC. It received FDA 510(k) clearance on 2017-09-13 under approval number K163215. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AnemoCheck?

AnemoCheck is a medical device that received FDA 510(k) clearance on 2017-09-13. It is manufactured by Sanguina, LLC. The 510(k) number is K163215.

When was AnemoCheck approved by the FDA?

AnemoCheck received FDA 510(k) clearance on 2017-09-13, under approval number K163215.

What company makes AnemoCheck?

AnemoCheck is manufactured by Sanguina, LLC.

What is the FDA product code for AnemoCheck?

The FDA product code for AnemoCheck is KHG.

Related Devices (Code: KHG)

Official Source

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