Vitalograph In2itive User Manual
Cat. No. 07514
Issue 5
Page 44 of 45 DT_0006-6
D
ECLARATION OF
C
ONFORMITY
Product
:
Model 2120 Hand Held Spirometer
Vitalograph
In2itive™
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.
•
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
