FDA 510(k) Applications Submitted by FUKUDA DENSHI USA, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K970585 02/14/1997 FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR FUKUDA DENSHI USA, INC.
K980728 02/25/1998 FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM FUKUDA DENSHI USA, INC.
K000746 03/08/2000 FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX FUKUDA DENSHI USA, INC.
K980979 03/17/1998 FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE FUKUDA DENSHI USA, INC.
K981066 03/24/1998 FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH FUKUDA DENSHI USA, INC.
K971131 03/27/1997 FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR FUKUDA DENSHI USA, INC.
K981404 04/17/1998 FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 FUKUDA DENSHI USA, INC.
K971440 04/18/1997 FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH FUKUDA DENSHI USA, INC.
K963057 08/06/1996 FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER FUKUDA DENSHI USA, INC.
K955416 11/27/1995 CARDIMAX MODEL FX-2111 FUKUDA DENSHI USA, INC.
K955543 12/05/1995 ULTRASOUND SYSTEM MODEL UF-3500 FUKUDA DENSHI USA, INC.
K150030 01/08/2015 Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor Fukuda Denshi USA, Inc.
K112521 08/31/2011 FUKUDA DENSHI VASERA MODEL VS-1500 FUKUDA DENSHI USA, INC.
K173226 10/03/2017 CardiMax Electrocardiograph Fukuda Denshi USA, Inc.
K103134 10/25/2010 FUKUDA DENSHI FUKUDA DENSHI USA, INC.
K083697 12/15/2008 FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M FUKUDA DENSHI USA, INC.
K134046 12/31/2013 FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR FUKUDA DENSHI USA, INC.
K013273 10/01/2001 FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE FUKUDA DENSHI USA, INC.
K020084 01/10/2002 FUKUDA DENSHI DYNASCOPE MODEL DS-5700 FUKUDA DENSHI USA, INC.
K040246 02/03/2004 FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR FUKUDA DENSHI USA, INC.
K050363 02/14/2005 FUKUDA DENSHI MODEL UF-850XTD FUKUDA DENSHI USA, INC.
K032290 07/24/2003 FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR FUKUDA DENSHI USA, INC.
K033209 10/03/2003 FUKUDA DENSHI MODEL FF SONIC UF-750XT FUKUDA DENSHI USA, INC.
K033711 11/26/2003 FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM FUKUDA DENSHI USA, INC.
K082656 09/12/2008 MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT FUKUDA DENSHI USA, INC.
K990401 02/09/1999 FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER FUKUDA DENSHI USA, INC.
K081891 07/02/2008 FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR FUKUDA DENSHI USA, INC.
K964187 10/21/1996 FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR FUKUDA DENSHI USA, INC.


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