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
Jan 7, 2009K081924CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE
Calhealth, Inc., CN
DXN
Dec 17, 2008K081498TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
Biocomfort Diagnostics GmbH & Co. KG, DE
DXN
Dec 12, 2008K081852TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
Truly Instrument Limited, CN
DXN
Nov 26, 2008K083078QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200
Quanta Computer, Inc.
DXN
Nov 24, 2008K082881MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3
Microlife Intellectual Property GmbH
DXN
Nov 13, 2008K082734A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR
A&D Engineering, Inc.
DXN
Oct 29, 2008K082357MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).
Microlife Intellectual Property GmbH
DXN
Oct 27, 2008K083043KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
Shenzhen Kingyield Technology Co., Ltd., CN
DXN
Oct 17, 2008K082599NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT
Cnsystem Medizintechnik AG, AT
DXN
Oct 10, 2008K081654HEM-9000AI
Omron Healthcare, Inc.
DXN
Aug 8, 2008K081159HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
Harvard Medical Devices , Ltd., HK
DXN
Jul 31, 2008K080326KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Andon Health Co, Ltd., CN
DXN
Jul 31, 2008K072109STATMAP, MODEL 7200
Ramsey Medical, Inc.
DXN
Jul 2, 2008K080319KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Andon Health Co, Ltd., CN
DXN
Jun 19, 2008K081590YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J
Ya Horng Electronic Co., Ltd., TW
DXN
May 13, 2008K080337MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
Microlife Corp.
DXN
May 9, 2008K080177WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
Nihon Seimitsu Sokki Co., Ltd., JP
DXN
Apr 23, 2008K080274AMBULO 2400
Tiba Medical, Inc.
DXN
Apr 3, 2008K080789BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202
Sejoy Electronics & Instruments Co., Ltd.
DXN
Apr 2, 2008K073445CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
Taidoc Technology Corporation, TW
DXN
Feb 26, 2008K0802891500 PRO
Omron Healthcare, Inc.
DXN
Feb 25, 2008K072860YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500
Ya Horng Electronic Co., Ltd., TW
DXN
Jan 11, 2008K073630MODIFICATION TO: BPCARD, MODEL Z-7000-0700
Qrs Diagnostic, LLC
DXN
Jan 11, 2008K073198MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)
Microlife Intellectual Property GmbH
DXN
Dec 20, 2007K073398MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)
Microlife Corp.
DXN
Dec 20, 2007K073397MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)
Microlife Corp.
DXN
Dec 7, 2007K072137AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB
Avita Corporation
DXN
Nov 29, 2007K072446MOBIL-O-GRAPH NG 24 H ABP-CONTROL
I.E.M. GmbH
DXN
Nov 29, 2007K072049CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS
Bmeye B.V.
DXN
Nov 15, 2007K072593A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE
Healthstats International Pte. , Ltd.
DXN
Oct 9, 2007K071384MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
Nihon Seimitsu Sokki Co., Ltd., JP
DXN
Sep 7, 2007K072272HONEYWELL HOMMED CENTRAL STATION 4.0
Honeywell Hommed, LLC
DXN
Aug 15, 2007K070828KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Kodon(Tianjin)Electronic&Electrical Apparatus Co.,, CN
DXN
Aug 15, 2007K070826KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
Kodon(Tianjin)Electronic&Electrical Apparatus Co.,, CN
DXN
Aug 13, 2007K062974TESLA NIBP
Mammendorfer Institut Fur Physik Und Medizin GmbH
DXN
Aug 8, 2007K070209FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR
Fego Precision Industrial Co;, Ltd.
DXN
Aug 3, 2007K071960MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05
Meditech Kft., IL
DXN
Jun 26, 2007K071523FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750
Genexel-Sein, Inc.
DXN
Jun 7, 2007K070395KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Kodon(Tianjin)Electronic&Electrical Apparatus Co.,, CN
DXN
Jun 7, 2007K063008HEALTH CHECK KIOSK
Xperex Corporation
DXN
May 25, 2007K071075TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
Terumo Corp., JP
DXN
May 25, 2007K070825LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
Little Doctor (Shanghai) Electronic Manufacturing, CN
DXN
May 23, 2007K070473BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX
Zen Strong Medical Technology Co., Ltd., TW
DXN
May 10, 2007K070086SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
Sensacare , Ltd., TW
DXN
May 2, 2007K070750247 BP DEVICE
Suntech Medical, Inc.
DXN
May 1, 2007K063137PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000
Pharmasmart, Inc.
DXN
Mar 23, 2007K062033BP 101 DIGITAL BLOOD PRESSURE MONITOR
Kingyield Hongkong Limited, HK
DXN
Mar 7, 2007K063814BP-200 PLUS
Schiller AG, CH
DXN
Feb 5, 2007K062893KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
Shanghai Kodea Economic and Trade Development , Ltd., CN
DXN
Feb 1, 2007K063111FINOMETER MODEL-2 WITH ACCESSORIES
Finapres Medical Systems B.V., NL
DXN

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