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 25, 2010K092106U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132
Taidoc Technology Corporation, TW
DXN
Jan 22, 2010K093823FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM
Health & Life Co., Ltd., TW
DXN
Jan 14, 2010K092893TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES
Tytan Medical Corp., TW
DXN
Jan 13, 2010K092811FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903
Andon Health Co, Ltd., CN
DXN
Jan 8, 2010K093013BLOOD PRESSURE MONITOR, MODEL MD200A
Beijing Choice Electronic Technololgy Co., Ltd., CN
DXN
Dec 29, 2009K092588FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918
Andon Health Co, Ltd., CN
DXN
Dec 23, 2009K093452FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
Andon Health Co, Ltd., CN
DXN
Dec 23, 2009K092510FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911
Andon Health Co, Ltd., CN
DXN
Dec 4, 2009K093528FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
Andon Health Co, Ltd., CN
DXN
Dec 4, 2009K092514UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
Hangzhou Hua'An Medical & Health Instruments Co.,, CN
DXN
Nov 27, 2009K093387FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902
Andon Health Co, Ltd., CN
DXN
Nov 27, 2009K0933591103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133
Shanghai Little Doctor Co. Limited, CN
DXN
Nov 17, 2009K093389CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
Computerized Screening, Inc.
DXN
Nov 16, 2009K092163FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
Health & Life Co., Ltd., TW
DXN
Oct 23, 2009K092456MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
Microlife Intellectual Property GmbH
DXN
Oct 21, 2009K091414VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
Biocare Corp., TW
DXN
Oct 9, 2009K092806AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
K-Jump Health Co., Ltd., TW
DXN
Oct 9, 2009K092432AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)
Jawon Medical Co., Ltd., KR
DXN
Sep 30, 2009K092161FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
Health & Life Co., Ltd., TW
DXN
Sep 25, 2009K092683DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
Shanghai Little Doctor Co. Limited, CN
DXN
Sep 21, 2009K091553BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
Ningbo Diaier Electronic Co., Ltd., CN
DXN
Sep 18, 2009K092719DIGITAL BLOOD PRESSURE MONITOR
Shanghai Little Doctor Electronic Co., Ltd., CN
DXN
Sep 4, 2009K091434TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
Truly Instrument Co., Ltd., CN
DXN
Sep 4, 2009K091415TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M
Truly Instrument Co., Ltd., CN
DXN
Aug 25, 2009K091897BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
Taidoc Technology Corporation, TW
DXN
Aug 25, 2009K091821COMMANDER 111, MODEL CD300-CD399
Cardiocom, LLC
DXN
Aug 18, 2009K091739SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909
Andon Health Co, Ltd., CN
DXN
Aug 18, 2009K091738SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD
Andon Health Co, Ltd., CN
DXN
Aug 18, 2009K091737FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
Andon Health Co, Ltd., CN
DXN
Jul 31, 2009K091500MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
Andon Health Co, Ltd., CN
DXN
Jul 30, 2009K092045FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739
Andon Health Co, Ltd., CN
DXN
Jul 30, 2009K091997FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962
Andon Health Co, Ltd., CN
DXN
Jun 19, 2009K083753SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU
K-Jump Health Co., Ltd., TW
DXN
Jun 4, 2009K090772FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909
Andon Health Co, Ltd., CN
DXN
Jun 4, 2009K090771FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962
Andon Health Co, Ltd., CN
DXN
Jun 4, 2009K090770FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905
Andon Health Co, Ltd., CN
DXN
Jun 4, 2009K090769FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961
Andon Health Co, Ltd., CN
DXN
Jun 4, 2009K090768FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909,
Andon Health Co, Ltd., CN
DXN
May 8, 2009K091068ACCUTORR V MONITOR, MODEL 0998-00-2000
Datascope Corp., Patient Monitoring Division
DXN
Apr 30, 2009K090963FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
Andon Health Co, Ltd., CN
DXN
Apr 22, 2009K090058YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB
Ya Horng Electronic Co., Ltd., TW
DXN
Feb 27, 2009K083395SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598
Andon Health Co, Ltd., CN
DXN
Feb 2, 2009K090027BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107
Zen Strong Medical Technology Co., Ltd., TW
DXN
Jan 29, 2009K083319FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941
Andon Health Co, Ltd., CN
DXN
Jan 29, 2009K083318FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904
Andon Health Co, Ltd., CN
DXN
Jan 29, 2009K083317FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902
Andon Health Co, Ltd., CN
DXN
Jan 29, 2009K083248FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902
Andon Health Co, Ltd., CN
DXN
Jan 29, 2009K083247FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906
Andon Health Co, Ltd., CN
DXN
Jan 29, 2009K083246FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961
Andon Health Co, Ltd., CN
DXN
Jan 16, 2009K083681BIOLAND BLOOD PRESSURE MONITOR
Bioland Technology, Ltd., HK
DXN

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