Regulatory and quality

Licensed. Audited. Secure.

Only verified licences and certifications appear here.

India

CDSCO

Class B under MDR 2017. Manufacturing licence MH/M/MD/001068.

Quality

ISO 13485

Quality management system certified to ISO 13485, with MDSAP.

USA

US FDA

alveoair: 510(k) cleared (K222525, August 2023). alveoflow: 510(k) submission pending.

  1. Acquisition time of 15–30 seconds of tidal breathing per recording, from the alveoflow FOT System specification. Applies to alveoflow Pro and alveoflow Neo.
  2. FHIR R4 and HL7 v2 export from the alveoflow FOT System specification. ABDM integration supported.
  3. CDSCO Class B under MDR 2017. ISO 13485 and MDSAP as stated on alveo.fit. alveoflow: US 510(k) submission pending; not cleared for sale in the United States. alveoair is US FDA 510(k) cleared (K222525, August 2023).
  4. Screens show example data and do not represent a real patient. Interpretation is the responsibility of the treating clinician.