FDA 510(k)

AnemoCheck

K-Number: K163215 · 2017-09-13

Decision Date2017-09-13

Product CodeKHG

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

AnemoCheck is the device name listed in this FDA 510(k) record. The listed applicant is Sanguina, LLC. It received FDA 510(k) clearance on 2017-09-13 under 510(k) 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. The listed applicant is Sanguina, LLC. The 510(k) number is K163215.

When did AnemoCheck receive FDA 510(k) clearance?

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

Who is the listed applicant for AnemoCheck?

The FDA 510(k) record lists Sanguina, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AnemoCheck?

The FDA product code for AnemoCheck is KHG.

Other records listing Sanguina, LLC 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.

K221508AnemoCheck Home

Related Devices (Code: KHG)

K221508AnemoCheck HomeSanguina, Inc.

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.