QStat Cartridge
K-Number: K213917 · 2022-11-29
ApplicantHemosonics, LLC
Decision Date2022-11-29
Product CodeQFR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
QStat Cartridge is a medical device manufactured by Hemosonics, LLC. It received FDA 510(k) clearance on 2022-11-29 under approval number K213917. The device is classified under product code QFR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the QStat Cartridge?
QStat Cartridge is a medical device that received FDA 510(k) clearance on 2022-11-29. It is manufactured by Hemosonics, LLC. The 510(k) number is K213917.
When was QStat Cartridge approved by the FDA?
QStat Cartridge received FDA 510(k) clearance on 2022-11-29, under approval number K213917.
What company makes QStat Cartridge?
QStat Cartridge is manufactured by Hemosonics, LLC.
What is the FDA product code for QStat Cartridge?
The FDA product code for QStat Cartridge is QFR.
Other Devices by Hemosonics, LLC
Related Devices (Code: QFR)
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.