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DT_0006 Issue 16
A Global Leader in Respiratory Solutions
17. EU Declaration of Conformity
Product: Vitalograph Model 6300 micro
Vitalograph hereby ensures and declares that 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 provisions 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.
Frank Keane.
CEO, Vitalograph Ltd.
