CARDIOSKIN
K-Number: K173248 · 2018-08-11
ApplicantBioserenity Sas
Decision Date2018-08-11
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CARDIOSKIN is a medical device manufactured by Bioserenity Sas. It received FDA 510(k) clearance on 2018-08-11 under approval number K173248. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CARDIOSKIN?
CARDIOSKIN is a medical device that received FDA 510(k) clearance on 2018-08-11. It is manufactured by Bioserenity Sas. The 510(k) number is K173248.
When was CARDIOSKIN approved by the FDA?
CARDIOSKIN received FDA 510(k) clearance on 2018-08-11, under approval number K173248.
What company makes CARDIOSKIN?
CARDIOSKIN is manufactured by Bioserenity Sas.
What is the FDA product code for CARDIOSKIN?
The FDA product code for CARDIOSKIN is DXH. This falls under the Hematology category.
Other Devices by Bioserenity Sas
Related Devices (Code: DXH)
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.