BISX4 Module - India CDSCO Medical Device Registration

BISX4 Module is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001168_3adb699448b4257eb48c7727b8c21f9e_150bff7adddfdc39214bdd86d33465ad. This device is marketed under the brand name BIS™. The license holder is India Medtronic 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

BISX4 Module

UID: IMP/MD/2023/001168_3adb699448b4257eb48c7727b8c21f9e_150bff7adddfdc39214bdd86d33465ad

Brand Name

BIS™

License Holder

India Medtronic Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The BIS Complete Monitor System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The system, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation