Spirometer - India CDSCO Medical Device Registration

Spirometer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000834_7cb407104cb2d917e2c129a8bf681b78_24971003291942093e4a26f85ab1d868. This device is marketed under the brand name PowerCube + Series. The license holder is Schiller Healthcare India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Spirometer

UID: IMP/MD/2023/000834_7cb407104cb2d917e2c129a8bf681b78_24971003291942093e4a26f85ab1d868

Brand Name

PowerCube + Series

License Holder

Schiller Healthcare India Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The SpiroScout is a PC-based ultrasonic system for measuring and analyzing breath flow and volume. The SpiroScout is intended for measuring and analyzing lung function parameters in adult and paediatric patients over 5 years of ages. The SpiroScout is intended for use in hospital and clinic settings for adult and paediatric patients. The SpiroScout is a PC-based ultrasonic system for measuring and analysing breath flow and volume. The Spirometry-Scout in combination with a spirometry software is intended for measuring and analysing lung function parameters. The SpiroScout is intended for use in hospital and clinic settings. The Spirometry-Scout is intended for measuring and analysing lung function parameters in adult and paediatric patients of all nationalities. No weight limitations apply. Contraindications must be observed. The Spirometry-Scout is intended to be used for adults and paediatric patients from an age of 2.5 years on. Tidal breath analysis can be used for paediatric patients from birth on.