+34 645 36 42 56
ESTUDIO DE FLUJOS
Nasal Advanced Systems of Airflow Lab, S.L.
C/Fortunata y Jacinta 23 1ºC 28020 Madrid
We hereby declare with full responsibility that the relevant quality
and safety properties of our product:
Device for the study of the behaviour of the respiratory air flow
for the purpose of diagnostics in the medical decision-making process
for the treatment of upper respiratory tract dysfunctions.
Classification According to Annex II, excluding section 4,
of the Directive 93/42/EEC, Rule10,
Fulfils the following fundamental requirements:
Medical Device Directive 93/42/EEC – Annex II
Conformity assessment is based on the following requirements:
EN ISO 13485:2012.
Medical Devices – Quality Management Systems.
EN ISO 14971:2012.
Medical Devices – Application of risk management to medical devices.
EN ISO 1041:2009.
Information supplied by the manufacturer of medical devices.
Medical device software – Software life cycle processes.
Application of usability engineering to medical devices.
Annex X of 93/42/EEC Directive.