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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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viewpoint telemetry system DATASCOPE CORP. k031760 10/10/2003
online tdm amika ROCHE DIAGNOSTICS CORP. k032279 10/10/2003
fukuda denshi dynascope model ds-7100 series portable patient monitor FUKUDA DENSHI USA, INC. k032290 10/10/2003
radiodexter version 1.0, dextroscope, model mk10 and dextrobeam, model mk3 VOLUME INTERACTIONS PTE LTD k032924 10/10/2003
modification to: mac-lab/cardiolab ep/combolab system GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES k032577 10/10/2003
orthophos xg ds/ceph SIRONA DENTAL SYSTEMS GMBH k033073 10/10/2003
replacement pump head door assembly, p1, model bx10468, replacement pump head door assembly, p2, model bx10469 AMERICAN I.V. PRODUCTS, INC. k032789 10/09/2003
cynosure smart file nd:yag lasers CYNOSURE, INC. k031125 10/09/2003
us-100 portable ultrasound therapy unit ITO CO., LTD. k032793 10/09/2003
ge 0.7t signa openspeed with excite mr system GE MEDICAL SYSTEMS, LLC k032795 10/08/2003

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