Hemodynamic Monitoring System
- UID
- IMP/MD/2021/000135_162e8bca984f1a185bbe400302552cf2_f9b6c70e179cdde359adc159fe5b3e0e
- Device class
- Class C
- Brand name
- FORE-SIGHT ELITE™ Tissue Oximeter Module
- License holder
- Edwards Lifesciences (India) Private Limited,
- Approving authority
- CDSCO
- Product information
- The noninvasive FORE-SIGHT ELITE module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor. • When used with large sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on adults and transitional adolescents ≥40 kg. • When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects ≥3 kg. • When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg
Hemodynamic Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000135_162e8bca984f1a185bbe400302552cf2_f9b6c70e179cdde359adc159fe5b3e0e. This device is marketed under the brand name FORE-SIGHT ELITE™ Tissue Oximeter Module. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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