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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K092785

COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 · Vasomedical, Inc. · decided 2010-04-02 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Vasomedical-Biox™ ARCS ABP Analysis & Reporting Software & DongleARCS Series S/WVASOMEDICAL, INC.DSH00817980020283
Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP MonitorModel 2303VASOMEDICAL, INC.DSH00817980020092
Vasomedical-Biox™ ARCS S/W & Dongle, Comb (3 CH ECG & ABP),USB w/BluetoothARCS Series S/WVASOMEDICAL, INC.DSH00817980020306
Vasomedical-Biox™ Model 2305 3 CH/ABP COMB Recorder w/BluetoothModel 2305 KitVASOMEDICAL, INC.DSH00817980020535
Vasomedical-Biox™ 2306 Combined 12 CH ECG Holter & ABP Monitor with BluetoothModel 2306VASOMEDICAL, INC.DSH00817980020122
Vasomedical-Biox™ ARCS Analysis & Reporting S/w & Dongle, 12 CH ECG, USBARCS Series S/WVASOMEDICAL, INC.DSH00817980020214
Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200 / 1201, 2 & 3 CH ECGARCS Series S/WVASOMEDICAL, INC.DSH00817980020313
Vasomedical-Biox™ ARCS S/W Dongle Only (3 CH ECG & ABP)ARCS Series S/WVASOMEDICAL, INC.DSH00817980020245
Vasomedical-Biox™ ARCS S/W & Dongle, Comb (12 CH ECG & ABP),USB w/BluetoothARCS Series S/WVASOMEDICAL, INC.DSH00817980020276
Vasomedical-Biox™ ARCS Analysis & Reporting S/W & Dongle, 3 CH ECG, USBARCS Series S/WVASOMEDICAL, INC.DSH00817980020177
Vasomedical-Biox™ ARCS ABP Analysis & Reporting S/W & Dongle w/BluetoothARCS Series S/WVASOMEDICAL, INC.DSH00817980020290
Vasomedical-Biox™ ARCS S/W & Dongle, Comb (12 CH ECG & ABP),USBARCS Series S/WVASOMEDICAL, INC.DSH00817980020252
Vasomedical-Biox™ 2305 Combined 3 CH ECG Holter & ABP Monitor with BluetoothModel 2305VASOMEDICAL, INC.DSH00817980020115
Vasomedical-Biox™ Model 2301 3 CH/ABP COMB Recorder - 7 Lead Patient CableModel 2301 KitVASOMEDICAL, INC.DSH00817980020504
Vasomedical-Biox™ ARCS Analysis & Reporting S/W Dongle Only, 12 CH ECGARCS Series S/WVASOMEDICAL, INC.DSH00817980020221
Vasomedical-Biox™ ARCS S/W Dongle Only (12 CH ECG & ABP)ARCS Series S/WVASOMEDICAL, INC.DSH00817980020269
Vasomedical-Biox™ ARCS Analysis & Reporting Software Dongle Only, 3 CH ECGARCS Series S/WVASOMEDICAL, INC.DSH00817980020207
Vasomedical-Biox™ ARCS S/W Dongle - Mini 1200/1201 2 & 3 CH ECGARCS Series S/WVASOMEDICAL, INC.DSH00817980020337
Vasomedical-Biox™ Model 2301 3 CH/ABP COMB Recorder - 5 Lead Patient CableModel 2301 KitVASOMEDICAL, INC.DSH00817980020498
Vasomedical-Biox™ Model 2303 3 CH/ABP COMB RecorderModel 2303 KitVASOMEDICAL, INC.DSH00817980020511
Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200/1201 2 & 3 CH ECG, USBARCS Series S/WVASOMEDICAL, INC.DSH00817980020320
Vasomedical-Biox™ ARCS S/W & Dongle, Comb (3 CH ECG & ABP), USBARCS Series S/WVASOMEDICAL, INC.DSH00817980020238
Vasomedical-Biox™ 2304 Combined 12 Channel ECG Holter & ABP MonitorModel 2304VASOMEDICAL, INC.DSH00817980020108
Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP MonitorModel 2301VASOMEDICAL, INC.DSH00817980020078