Tissue Oximetry Sensor - India CDSCO Medical Device Registration

Tissue Oximetry Sensor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000692_7c14e9e046683098fbeac78acadc3480_91b75c719864297631cf069fa6b4e68c. This device is marketed under the brand name ForeSight Large Sensor. 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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CDSCO Registered

Class Class C

Tissue Oximetry Sensor

UID: IMP/MD/2022/000692_7c14e9e046683098fbeac78acadc3480_91b75c719864297631cf069fa6b4e68c

Brand Name

ForeSight Large Sensor

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class C

Approving Authority

CDSCO

Product Information

When used in conjunction with the FORE-SIGHT ELITE absolute tissue oximeter or ForeSight oximeter cable: The small sensor is indicated for monitoring of absolute regional hemoglobin oxygen saturation of blood under the sensor in individuals at risk for reduced flow or no-flow ischemic states. It is intended for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects < 5 kg.