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CE Declaration of Conformity

CE Declaration of Conformity

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<strong>Declaration</strong> <strong>of</strong> <strong>Conformity</strong>Manufacturer:Authorized Representative:Product:Classification:Directives:Analytical Industries Inc.2855 Metropolitan PlacePomona, California 91767 USATel: 909-392-6900, Fax: 909-392-3665e-mail: sales-medical@aii1.comRGV Lda.Rua Jose Joaquim de Freitas, 2472750-404 Cascais-PortugalAII 2000, AII 2000A, AII 2000HC, AII 2000 Palm O2 Oxygen AnalyzersAII 2000M Oxygen MonitorOxygen Sensors - See Attachment AIIbMedical Device Directive 93/42/EEC, Annex II as amended by 2007/47/ECStandards & Certificates: ISO 9001:2008MDD 93/42/EEC, Annex II as amended by 2007/47/EC, Certificate 485<strong>CE</strong>ISO 13485:2003, Certificate 485BEN 12598:1999 (ISO 7767: 1997) Oxygen units for patient breathingmixtures – Safety requirementsNotified Body:AMTAC Certification Services LimitedDavy Avenue, KnowhillMilton Keynes MK5 8NLUnited KingdomDate <strong>CE</strong> mark affixed: February 21, 2006We hereby declare the above product meets the provisions <strong>of</strong> the directives and standards specified. Allsupporting documents are retained on the premises <strong>of</strong> the manufacturer and the notified body.Patrick Prindible, QA ManagerRev 8/12Page 2 <strong>of</strong> 2


Attachment AList <strong>of</strong> Oxygen SensorsAII-11-60AII-75-PO2PSR-11-915PSR-11-915-1PSR-11-60-3 ERT-P-1968-05 PSR-11-915-2PSR-11-60-08PSR-11-60-23PSR-11-915-2iPSR-11-915-3PSR-11-33 51250 PSR-11-915-4PSR-11-915GPSR-11-915-J3902646-00 PSR-11-917-J1 1001454PSR-11-915-J2PSR-11-917-J3PSR-11-915-J5PSR-11-917-J6PSR-11-917-J7PSR-11-75-KE2 PSR-11-917-M ERT-BMCF-1968-01PSR-11-75-KE4 ERT-V-1968-02 PSR-11-917-M1PSR-11-75-KE6 ERT-S2-1968-03 PSR-11-917-M2PSR-11-75-KE7PSR-11-917-MCCPSR-11-75-KE8 ERT-S5-1968-04 PSR-11-917-MH 51254, 396008PSR-11-75-KE9PSR-11-33-1PSR-11-33-2PSR-11-37-202-2PSR-11-55PSR-11-58PSR-11-58HCPSR-11-58-15PSR-11-75-KE1PSR-11-75-KE10+PSR-11-917-MH1PSR-11-917-MH3PSR-11-77Rev 8/12Page 2 <strong>of</strong> 2

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