Device Listing 1341439408

Listing Summary#

Listing key
1341439408
Premarket submission
K223865
Device
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
Applicant
Edwards Lifesciences, LLC
Product code
DQK
Decision date
2023-06-09