Patient Monitor
- UID
- IMP/MD/2022/000571_726df8b7ed89f5266682d80c80921043_2d71785e42da3cd3f63bb76cf3a00b3b
- Device class
- Class B
- Brand name
- INVOS PM7100
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use on individuals > 2.5 kg at risk for reduced-flow or no-flow ischemic states. For patients ≤ 2.5kg, the INVOS™ Patient Monitor, model PM7100 is only intended for adjunct trend monitoring of regional hemoglobin oxygen saturation of blood tissue beneath the sensor. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood tissue beneath the sensor in any individual.
Patient Monitor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000571_726df8b7ed89f5266682d80c80921043_2d71785e42da3cd3f63bb76cf3a00b3b. This device is marketed under the brand name INVOS PM7100. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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