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HemoSphere Advanced Monitor (HEM1) +9 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K243781
Identifiers
- 510(k) Number
- K243781 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
- Models / Variants
- HemoSphere Advanced Monitor (HEM1) FDA 510(k)HemoSphere Technology Module (HEMTOM10) FDA 510(k)HemoSphere ClearSight Module (HEMCSM10) FDA 510(k)Smart Pressure Controller (PC1Q) FDA 510(k)Acumen IQ Plus Finger Cuff (AIQCA2) FDA 510(k)HemoSphere Pressure Cable (HEMPSC100) FDA 510(k)HemoSphere Vita Monitor (HEMVITA1) FDA 510(k)HemoSphere Vita Technology Module (HEMVTOM1) FDA 510(k)HemoSphere VitaWave module (HEMVWM1) FDA 510(k)VitaWave Plus finger cuff (VWCA2) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
HemoSphere Advanced Monitor (HEM1) +9 more models by Edwards Lifesciences — Class II — FDA_510K — listed in FDA 510(k) — 10 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243781 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences
Sources (1)
- FDA 510(k) K243781 24 fields · synced Jun 18, 2026