Blood Pressure Monitoring Device - India CDSCO Medical Device Registration

Blood Pressure Monitoring Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000026_d3ddd5545e443c60f699a2b920afa192_2235486f99c191e41127239628dc5040. This device is marketed under the brand name Acumen IQ Finger Cuff. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Blood Pressure Monitoring Device

UID: IMP/MD/2018/000026_d3ddd5545e443c60f699a2b920afa192_2235486f99c191e41127239628dc5040

Brand Name

Acumen IQ Finger Cuff

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class B

Approving Authority

CDSCO

Product Information

Intended Use: The ClearSight™ finger cuff is intended to non-invasively and continuously measure blood pressure and hemodynamic parameters in adult patients. Indications - The EV1000 clinical platform NI and ClearSight™ finger cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. The EV1000 clinical platform maybe used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 clinical platform NI and ClearSight™ finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters

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