Defibrillator - India CDSCO Medical Device Registration
Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000585_573af448e4733b7079213ab73a413dcb_0442471e8ef6a81af603b922bde0b1d6. This device is marketed under the brand name LIFEPAK 20e Monitor/Defibrillator and accessories. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
LIFEPAK 20e Monitor/Defibrillator and accessories
License Holder
M/s Stryker India Private Ltd.,Device Class
Approving Authority
CDSCO
Product Information
The intended use for the LIFEPAK 1000 Defibrillator is emergency treatment of patients in cardiac arrest. It can operate in manual or semiautomatic mode. A lesser trained emergency responder can use the device in the semi-automated mode; the device analyzes the cardiac rhythm and indicates “shock advised” if it detects a shockable rhythm. If the device is in the manual mode a person trained in cardiac rhythm interpretation such as a paramedic can deliver a defibrillation shock without relying on the automated analysis of the device
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Brand: LIFEPAK 20e Monitor/Defibrillator and accessories