15. DECLARATION OF CONFORMITY
Product: Model 4130 Vitalograph BT12 ECG
Vitalograph hereby ensures and declares that the above product associated with this user manual, 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.
FDA Quality System Regulation {QSR} 21 CFR 820.
EN ISO 13485: 2012. Medical devices. Quality management systems. Requirements for regulatory purposes.
Certifying Body: British Standards Institute {BSI}.
{For 93/42/EEC and CMDR}.
BSI Notified Body #: 0086
Certificate Nos. CE 00772, CE 85553, MD 82182
Signed on behalf of Vitalograph (Ireland) Ltd.
B. R. Garbe.
Group Managing Director
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