Patient Physiologic Monitoring System
- UID
- IMP/MD/2023/001188_4471bcce83e658ef5d76b7b76bfae31a_fef4e1f269de14802c5cbe77dadd572b
- Device class
- Class C
- Brand name
- Mac-Lab, CardioLab, ComboLab, MLCL Client Software AltiX System
- License holder
- Wipro GE Healthcare Private Limited
- Approving authority
- CDSCO
- Product information
- The Mac-Lab system is intended for recording hemodynamic clinical data, and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations. The CardioLab system is intended for recording electrophysiology clinical data, and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations. The ComboLab system is the combination of both the Mac-Lab and CardioLab systems intended for recording hemodynamic and electrophysiology clinical data, respectively and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations. The MLCL Client Software is intended for recording, documenting and/or reviewing clinical data for hemodynamic and electrophysiology procedures and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.
Patient Physiologic Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001188_4471bcce83e658ef5d76b7b76bfae31a_fef4e1f269de14802c5cbe77dadd572b. This device is marketed under the brand name Mac-Lab, CardioLab, ComboLab, MLCL Client Software AltiX System. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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