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510(k) K050363

FUKUDA DENSHI MODEL UF-850XTD by Fukuda Denshi USA, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2005
Date Received
February 14, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K082656 — MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT (September 30, 2008)
  • K081891 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR (August 29, 2008)
  • K033711 — FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM (June 3, 2004)
  • K040246 — FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR (May 26, 2004)

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