Automated External Defibrillator - India CDSCO Medical Device Registration

Automated External Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000350_158c6010528b370ac459cf30b55600c8_c925e42b986f564364151b3e4a948f10. This device is marketed under the brand name HeartStart FRx. The license holder is PHILIPS INDIA LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Automated External Defibrillator

UID: IMP/MD/2021/000350_158c6010528b370ac459cf30b55600c8_c925e42b986f564364151b3e4a948f10

Brand Name

HeartStart FRx

License Holder

PHILIPS INDIA LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The FRx is indicated for the termination of ventricular fibrillation (HeartStart FRx), ventricular flutter and some ventricular tachycardia (HeartStart FRx) in the following populations: • Infants and children under 25 kilograms / 55 pounds or 0-8 years old • Children and adults over 25 kilograms / 55 pounds or greater than 8 years old

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Brand: HeartStart FRx

PHILIPS INDIA LIMITED

Class C

Brand: OmniLab Advanced +

Class B