Patient Monitor - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

Patient Monitor

UID: IMP/MD/2022/000571_726df8b7ed89f5266682d80c80921043_2d71785e42da3cd3f63bb76cf3a00b3b

Brand Name

INVOS PM7100

License Holder

India Medtronic Private Limited

Device Class

Class B

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.