Device Listing 1732095306
Listing Summary#
- Listing key
- 1732095306
- Premarket submission
- K243781
- Device
- HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)
- Applicant
- Edwards Lifesciences
- Product code
- DQK
- Decision date
- 2025-07-23