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16. EU Declaration of Conformity
Product: MD6300 Micro Spirometer
The manufacturer hereby ensures and declares the above product
associated with these instructions for use, is designed and manufactured
in accordance with the following QMS regulations and standards.
•
European Medical Devices Directive {MDD} 93/42/EEC, as
amended.
This device is classified as IIa per Annex IX of the MDD also
meets the provision of the Essential Requirements, Annex I, via
compliance with Annex II of the Medical Devices Directive as per
Article 11, section 3a, excluding point 4 of Annex II.
•
Canadian Medical Device Regulation {CMDR SOR/98-282}.
•
FDA Quality System Regulation {QSR} 21 CFR 820.
•
EN ISO 13485 Medical devices. Quality management systems.
Requirements for regulatory purposes
Certifying Body: British Standards Institute {BSI}.
BSI Notified Body #: 2797
Certificate Nos. CE 00772, MD 82182
Signed on behalf of Vitalograph (Ireland) Ltd.
