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_49b257676d048f4292fbd4019cdd4f3a. This device is marketed under the brand name Fore-Sight Elite Large Sensor. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Tissue Oximetry Sensor

UID: IMP/MD/2022/000692_7c14e9e046683098fbeac78acadc3480_49b257676d048f4292fbd4019cdd4f3a

Brand Name

Fore-Sight Elite Large Sensor

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class B

Approving Authority

CDSCO

Product Information

When used in conjunction with the FORE-SIGHT ELITE absolute tissue oximeter or Fore-Sight Elite tissue oximetry module: 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 less than (Fore-Sight Elite Large Sensor) 8 kg and non-cerebral use on pediatric subjects less than (Fore-Sight Elite Large Sensor) 5 kg.