Biovitals Analytics Engine
K-Number: K183282 · 2019-08-15
ApplicantBiofourmis Singapore Pte., Ltd.
Decision Date2019-08-15
Product CodePLB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Biovitals Analytics Engine is a medical device manufactured by Biofourmis Singapore Pte., Ltd.. It received FDA 510(k) clearance on 2019-08-15 under approval number K183282. The device is classified under product code PLB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biovitals Analytics Engine?
Biovitals Analytics Engine is a medical device that received FDA 510(k) clearance on 2019-08-15. It is manufactured by Biofourmis Singapore Pte., Ltd.. The 510(k) number is K183282.
When was Biovitals Analytics Engine approved by the FDA?
Biovitals Analytics Engine received FDA 510(k) clearance on 2019-08-15, under approval number K183282.
What company makes Biovitals Analytics Engine?
Biovitals Analytics Engine is manufactured by Biofourmis Singapore Pte., Ltd..
What is the FDA product code for Biovitals Analytics Engine?
The FDA product code for Biovitals Analytics Engine is PLB.
Other Devices by Biofourmis Singapore Pte., Ltd.
Related Devices (Code: PLB)
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.