Electroencephalograph system
- UID
- IMP/MD/2023/000568_9f1dbf8e9e238cfe91d83a0e0a648615_864077e669b6cd8a41edbdc605866f55
- Device class
- Class C
- Brand name
- IONM
- License holder
- Morulaa Health Tech Pvt Ltd
- Approving authority
- CDSCO
- Product information
- The Cadwell Arc Essentia is indicated for prescription use to acquire, record, transmit and display physiological and environmental data for electroencephalographic (IONM) and/or clinical studies of patients of all ages. Use of Cadwell Arc Systems are to be administered by a trained medical professional under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in a suitable clinic or operating room.
Electroencephalograph system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000568_9f1dbf8e9e238cfe91d83a0e0a648615_864077e669b6cd8a41edbdc605866f55. This device is marketed under the brand name IONM. The license holder is Morulaa Health Tech Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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