Regulation 2019-03-06T12:01:14+00:00

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,
Class IIa

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.

IEC 62304:2006. Medical device software – Software life cycle processes.

UNE‐EN 62366‐1:2015. Application of usability engineering to medical devices.

Annex X of 93/42/EEC Directive. Clinical evaluation