FDA 510(k)

AnemoCheck Home

K-Number: K221508 · 2023-09-29

Decision Date2023-09-29

Product CodeKHG

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

AnemoCheck Home is the device name listed in this FDA 510(k) record. The listed applicant is Sanguina, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K221508. 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 Home?

AnemoCheck Home is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Sanguina, Inc.. The 510(k) number is K221508.

When did AnemoCheck Home receive FDA 510(k) clearance?

AnemoCheck Home received FDA 510(k) clearance on 2023-09-29, under 510(k) number K221508.

Who is the listed applicant for AnemoCheck Home?

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

What is the FDA product code for AnemoCheck Home?

The FDA product code for AnemoCheck Home is KHG.

Other records listing Sanguina, Inc. 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.

K163215AnemoCheck

Related Devices (Code: KHG)

K163215AnemoCheckSanguina, LLC

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.