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11. DECLARATION OF CONFORMITY
Product:
Vitalograph 4000 Respiratory Monitor lung monitor
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.
This device, classified as 2a as per Annex IX of MDD 93/42/EEC, meets the
following provisions of Annex II of the Medical Devices Directive as per Article
11, section 3a, excluding point 4 of Annex II.
This device complies with the EMC Directive 89/336/EC, conformance demonstrated by
following standard EN60601-1-2:2001.
Equipment classification: Residential.
Canadian Medical Device Regulation {CMDR}
FDA Quality System Regulation {QSR} 21 CFR 820.
EN ISO 13485: 2003. Medical devices. Quality management systems. Requirements for regulatory
purposes.
Certifying Body {for 93/42/EEC and CMDR}: British Standards Institute {BSI}
Certificate Nos. CE 00772, MD 82182, FM 83550
Signed on behalf of Vitalograph (Ireland) Ltd.
B. R. Garbe.
Group Managing Director
