AnemoCheck Home
K-Number: K221508 · 2023-09-29
ApplicantSanguina, Inc.
Decision Date2023-09-29
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
AnemoCheck Home is a medical device manufactured by Sanguina, Inc.. It received FDA 510(k) clearance on 2023-09-29 under approval 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. It is manufactured by Sanguina, Inc.. The 510(k) number is K221508.
When was AnemoCheck Home approved by the FDA?
AnemoCheck Home received FDA 510(k) clearance on 2023-09-29, under approval number K221508.
What company makes AnemoCheck Home?
AnemoCheck Home is manufactured by Sanguina, Inc..
What is the FDA product code for AnemoCheck Home?
The FDA product code for AnemoCheck Home is KHG.
Related Devices (Code: KHG)
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.