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
Oct 15, 1999K983616DAIWA MODEL 180
Daiwa Products, Inc.
DXN
Oct 7, 1999K990638ANEROID SPHYGMOMANOMETER
Genmed, Inc.
DXN
Sep 16, 1999K983717BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
Aerotel Medical Systems (1998) , Ltd., IL
DXN
Sep 1, 1999K992808A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE
A&D Medical Div.
DXN
Sep 1, 1999K990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
Physio-Control Corp.
DXN
Aug 10, 1999K990648KELLER VITAL SIGNS MONITOR, KMS 890+
Keller Medical Specialties Products, Inc.
DXN
Jul 21, 1999K992328FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
Meditec Co., Ltd., KR
DXN
Jun 1, 1999K991688WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S
Jawon Medical Co., Ltd.
DXN
May 13, 1999K983575ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
Datascope Corp.
DXN
Apr 28, 1999K984223BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
Citizen Watch Co., Ltd.
DXN
Mar 29, 1999K982641ADVANCED NIBP MODULE
Johnson & Johnson Medical, Inc.
DXN
Mar 25, 1999K984618BCI MINI-TORR PLUS, MODEL 6004
Bci Intl., Inc.
DXN
Mar 5, 1999K981702AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300
Nihon Seimitsu Sokki Co., Ltd.
DXN
Mar 3, 1999K981542PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
Panasonic Corporation (Panasonic)
DXN
Mar 3, 1999K981431PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280
Panasonic Corporation (Panasonic)
DXN
Mar 2, 1999K964235ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
Industrielle Entwicklung Medizintechnik Und Vertri
DXN
Feb 22, 1999K990380(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700
Meditec Co., Ltd., KR
DXN
Jan 22, 1999K9837966004 NIBP MONITOR WITH TEMPERATURE
Bci Intl., Inc.
DXN
Dec 14, 1998K980845MS-900S, MS-900SPM & MS-900SFM
Mars Medical Products
DXN
Nov 17, 1998K983855FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
Jawon Medical Co., Ltd., KR
DXN
Sep 25, 1998K982481A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR
A&D Engineering, Inc.
DXN
Sep 25, 1998K973637PRESS-MATE ADVANTAGE
Colin Medical Instruments Corp.
DXN
Sep 15, 1998K982135OSCILLOMATE EMS NIBP MONITOR MODEL 9001
Cas Medical Systems, Inc.
DXN
Jun 11, 1998K964153ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000
Rossmax International , Ltd., TW
DXN
Apr 14, 1998K973613CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER
Foley & Lardner
DXN
Mar 19, 1998K980824A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
A&D Engineering, Inc.
DXN
Mar 13, 1998K973061CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)
Citizen Watch Co., Ltd.
DXN
Feb 20, 1998K972795CARDIO-CARD MANAGEMENT SYSTEM II
Nasiff Assoc., Inc.
DXN
Jan 16, 1998K974061RECHARGEABLE BATTERY PART NUMBER GL825-200
Alexander Mfg. Co.
DXN
Jan 2, 1998K970629TANGO NON-INVASIVE BLOOD PRESSURE MONITOR
Suntech Medical Instruments, Inc.
DXN
Nov 12, 1997K970801BCI MODEL 6004 NIBP MONITOR (6004)
Bci Intl., Inc.
DXN
Apr 1, 1997K954547CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER
Citizen Watch Co., Ltd.
DXN
Mar 12, 1997K961144MS-2000
Touritu Engineering Co., Inc.
DXN
Feb 11, 1997K964697AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
Advance Medical Device, Inc.
DXN
Nov 14, 1996K952827FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000
Sein Electronics Co., Ltd.
DXN
Nov 14, 1996K952826FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000
Sein Electronics Co., Ltd.
DXN
Sep 9, 1996K952882PERSONAL TELEMEDICINE SYSTEM
American Telecare, Inc.
DXN
Jul 25, 1996K952979HANC NETWORK
Healthtech Services Corp.
DXN
Jul 2, 1996K960319A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR
A&D Engineering, Inc.
DXN
Jun 17, 1996K955342OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER
Rashman Corp.
DXN
Mar 13, 1996K951193CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1
Tycos Instruments, Inc.
DXN
Jan 31, 1996K945215MARS DIGITAL BLOOD PRESSURE MONITOR
Mars Metal Co., Ltd.
DXN
Dec 28, 1995K952494DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR
Nihon Seimitsu Sokki Co., Ltd., JP
DXN
Nov 20, 1995K945138OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS
Invivo Research, Inc.
DXN
Oct 24, 1995K951977DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883
Integrated Display Technology, Ltd., HK
DXN
Oct 20, 1995K953472NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
Nellcor, Inc.
DXN
Jul 14, 1995K942543ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
Sankei Co., Ltd.
DXN
Jun 23, 1995K945111DYNAPULSE 5000A (DP5000A)
Pulse Metric, Inc.
DXN
May 10, 1995K942072MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND
Mabis Healthcare, Inc.
DXN
Mar 8, 1995K945947NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER
Nellcor, Inc.
DXN

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