FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
K-Number: K243966 · 2025-04-09
ApplicantFaceheart Corp.
Decision Date2025-04-09
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) is a medical device manufactured by Faceheart Corp.. It received FDA 510(k) clearance on 2025-04-09 under approval number K243966. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)?
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) is a medical device that received FDA 510(k) clearance on 2025-04-09. It is manufactured by Faceheart Corp.. The 510(k) number is K243966.
When was FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) approved by the FDA?
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) received FDA 510(k) clearance on 2025-04-09, under approval number K243966.
What company makes FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)?
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) is manufactured by Faceheart Corp..
What is the FDA product code for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)?
The FDA product code for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) is BZQ.
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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.