ClearanceBrief
Panels › Cardiovascular › Product code DXN · Class 2

System, Measurement, Blood-Pressure, Non-Invasive

Regulation 870.1130

30510(k)s in 12 months (1,226 all time)
0recalls in 12 months (36 all time)
33recalls that name a 510(k)
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Top companies in DXN

Company510(k)sRecalls
Andon Health Co, Ltd.680
Health & Life Co., Ltd.550
OMRON Healthcare, Inc.370
Microlife Intellectual Property GmbH330
A&D Engineering, Inc.250
Grandway Technology (Shenzhen) Limited210
Nihon Seimitsu Sokki Co., Ltd.180
Welch Allyn, Inc.123
Guangdong Transtek Medical Electronics Co., Ltd.140
JOYTECH Healthcare Co., Ltd.140
Decided510(k)Device and applicantCode
Feb 15, 1995K942423NAIS WRIST BLOOD PRESSURE METER
King & Spalding
DXN
Feb 15, 1995K942422PANASONIC WRIST BLOOD PRESSURE METER
King & Spalding
DXN
Feb 1, 1995K950249VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205
Medwave, Inc.
DXN
Jan 27, 1995K943081TRIMLINE 2000
Pymah Corp.
DXN
Jan 27, 1995K942546CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER
Dynatech/Nevada, Inc.
DXN
Dec 20, 1994K942163WINNER SELF-TAKING HOME BLOOD PRESSURE KIT
Winmed Instruments Mfg. Corp., TW
DXN
Nov 29, 1994K942649MINIMUS I; MINIMUS III, SANAPHON
Rud Riester GmbH & CO KG, DE
DXN
Nov 29, 1994K941490BLOOD PRESSURE METER MODEL NO. BPM888
Integrated Display Technology, Ltd., HK
DXN
Nov 28, 1994K942336AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Integrated Display Technology, Ltd., HK
DXN
Nov 14, 1994K941167NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)
Spacelabs Medical, Inc.
DXN
Oct 17, 1994K942871PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM
Colin Medical Instruments Corp.
DXN
Aug 15, 1994K942650BIG BEN
Rud Riester GmbH & CO KG, DE
DXN
Aug 10, 1994K934385MINIPACK 3100/3000 MODIFICATION
Pace Tech, Inc.
DXN
Aug 1, 1994K940620ROSSMAX INTERNATIONAL LIMITED ACCURACY BLOOD PRESSURE MONITOR
Quality Systems Design, Inc.
DXN
Aug 1, 1994K935782DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
Ohmeda Medical
DXN
Jul 27, 1994K943461VARIOUS TYPES OF MERCURIALS
Rud Riester GmbH & CO KG, DE
DXN
Mar 25, 1994K925295EXACTA-SPEZIAL
Rudolf Riester GmbH & Co. KG, DE
DXN
Feb 23, 1994K925294PRECISA
Rudolf Riester GmbH & Co. KG, DE
DXN
Feb 17, 1994K932823BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK
Portable Power Systems, Inc.
DXN
Jan 24, 1994K935872NAMTAI
Nam Tai Electronics (Canada) , Ltd., CA
DXN
Dec 29, 1993K935652NAMTAI
Nam Tai Electronics (Canada) , Ltd., CA
DXN
Dec 3, 1993K932109PROFILOMAT
Qmed, Inc.
DXN
Oct 7, 1993K923344ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR
Citizen Watch Co., Ltd.
DXN
Sep 17, 1993K925402OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300
Cas Medical Systems, Inc.
DXN
Jul 1, 1993K923595SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR
Advanced Medical Instruments, Inc.
DXN
Jul 1, 1993K921048BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST
Colin Medical Instruments Corp.
DXN
Jul 1, 1993K915697CRITIKON VITAL SIGNS MODULE
Critikon Company, LLC
DXN
May 13, 1993K930798OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
Omron Healthcare, Inc.
DXN
May 13, 1993K924910SYSTEM 7500 NIBP/SA02
Advanced Medical Instruments, Inc.
DXN
Dec 24, 1992K920778OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601
Omron Healthcare, Inc.
DXN
Dec 23, 1992K914823OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
Omron Healthcare, Inc.
DXN
Nov 20, 1992K924210NAMTAI ELECTRONIC BLOOD PRESSURE METER
Nam Tai Electronics (Canada) , Ltd., CA
DXN
Nov 6, 1992K914765SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS
Siemens Medical Electronics
DXN
Nov 3, 1992K921627DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101
Showa Engineering Co., Ltd.
DXN
Oct 9, 1992K921074BP PUMP
Bio-Tek Instruments, Inc.
DXN
Oct 9, 1992K912815NIBP 9225 COMBI
S & W Medico Teknik, DK
DXN
Sep 22, 1992K915468MODEL P-81 CRITIKON PRINTER
Critkon, Inc.
DXN
Sep 4, 1992K9142604240 DYNAMIC BP/HEART RATE MONITOR
Suntech Medical Instruments, Inc.
DXN
Jul 14, 1992K913844ACCUTRACKER DX
Suntech Medical Instruments, Inc.
DXN
Mar 27, 1992K913595DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
Koven and Assoc., Inc.
DXN
Mar 4, 1992K911645NGM NIBP MODULE
Datex Division Instrumentarium Corp.
DXN
Jan 22, 1992K911722OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630
Cas Medical Systems, Inc.
DXN
Dec 19, 1991K912588AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS
Sein Electronics Co., Ltd.
DXN
Nov 7, 1991K911871CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS
Cardiodyne, Inc.
DXN
Nov 6, 1991K913523AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
Omron Healthcare, Inc.
DXN
Oct 28, 1991K911965ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR
Citizen Watch Co., Ltd.
DXN
Sep 10, 1991K910643CASIO BP-100
Casio, Inc.
DXN
Sep 5, 1991K912530CARDIOCAP II(TM)
Datex Medical Instrumentation, Inc.
DXN
Aug 22, 1991K911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP
Biochem International, Inc.
DXN
Aug 7, 1991K912119DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212
A&D Engineering, Inc.
DXN

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