Electrocardiograph for Stress Test System - India CDSCO Medical Device Registration
Electrocardiograph for Stress Test System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000764_6201895a409858f0017db3e2d207c9e3_e30d3878f44252d21d6d4d3d33054a81. This device is marketed under the brand name Spandan. The license holder is Schiller Healthcare India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Andhra Pradesh.
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Brand Name
Spandan
License Holder
Schiller Healthcare India Pvt. Ltd.Device Class
Approving Authority
Andhra Pradesh
Product Information
SPANDAN is a 12 channel ECG device used for the recording, analysis and evaluation of ECG Recordings. Recordings made with SPANDAN can be used as a diagnostic aid for heart function and heart conditions. The diagnostic applications for which the SPANDAN is intended is in the diagnosis of cardiac abnormalities in the general population, detecting acute myocardial ischemia, and infarction in chest pain patients, etc. The SPANDAN is intended for use in hospitals, cardio logical units, out-patient clinical units, and general practice, for indoor use only. There is no danger for patients with pacemaker. Only operate the device in accordance with the specified technical data. The device is not designed for sterile use. Do not use this unit in areas where there is any danger of explosion or in the presence of flammable gases such as anaesthetic agents. This unit is CF classified and defibrillation protected, only when the original patient cable is used. However, as a safety precaution when possible, remove electrodes before defibrillation. Spandan is a 12 channel ECG device which is connected with Treadmill and its accessories and used for the recording, analysis and evaluation of ECG Recordings. Recordings made with the Spandan can be used as a diagnostic aid for heart function and heart conditions. It is designed for indoor use and can be used for all patients of both sexes, all races, and aged more than 5 years.
