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

Clearance record K111180

VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY · Vasomedical, Inc. · decided 2011-06-28 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Vasomedical-Biox™ 1304 12 Channel ECG Holter RecorderModel 1304VASOMEDICAL, INC.DSH00817980020023
Portable Case w/Belt for 1303 RecorderModel 1303VASOMEDICAL, INC.DSH00817980020610
12-Ch ECG Holter Patient Cable w/10 LeadsModel 1304VASOMEDICAL, INC.DSH00817980020580
Vasomedical-Biox™ Model 1306 12 CH Recorder - 10 Lead Patient CableModel 1306 KitVASOMEDICAL, INC.DSH00817980020436
Pediatric BP Cuff (small/child) 17-25cmModel 1805VASOMEDICAL, INC.DSH00817980020672
Vasomedical-Biox™ Model 1307 3 CH ULTRA RecorderModel 1307 KitVASOMEDICAL, INC.DSH00817980020443
Vasomedical-Biox™ CB Series Analysis & Reporting S/w - 3 & 12 CH ECG & ABPCB Series S/WVASOMEDICAL, INC.DSH00817980020160
USB SD Card ReaderModel 1303VASOMEDICAL, INC.DSH00817980020597
Vasomedical-Biox™ Model 1308 12 CH ULTRA Recorder w/BluetoothModel 1308 KitVASOMEDICAL, INC.DSH00817980020450
Infared Communication AdaptorModel 1805VASOMEDICAL, INC.DSH00817980020603
3-Ch ECG Holter Patient Cable w/7 LeadsModel 1303VASOMEDICAL, INC.DSH00817980020573
Adult BP Cuff (standard) 24-32cmModel 1805VASOMEDICAL, INC.DSH00817980020658
Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter RecorderModel 1308VASOMEDICAL, INC.DSH00817980020030
Portable case with Belt for 1304/1305 RecorderModel 1304VASOMEDICAL, INC.DSH00817980020627
Portable case with Belt for 2301/2302 RecordersModel 2301VASOMEDICAL, INC.DSH00817980020641
Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter RecorderModel 1307VASOMEDICAL, INC.DSH00817980020016
Portable case with Belt for 1805 MonitorModel 1303VASOMEDICAL, INC.DSH00817980020634
Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG & ABPCB Series S/WVASOMEDICAL, INC.DSH00817980020153
2GB SD Memory CardModel 1303VASOMEDICAL, INC.DSH00817980020559
Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 7 Lead Patient CableModel 1303 KitVASOMEDICAL, INC.DSH00817980020382
Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECGCB Series S/WVASOMEDICAL, INC.DSH00817980020146
Vasomedical-Biox™ 1303 Ultra Compact 3 Channel ECG Holter RecorderModel 1303VASOMEDICAL, INC.DSH00817980020191
3-Ch ECG Holter Patient Cable w/5 LeadsModel 1303VASOMEDICAL, INC.DSH00817980020566
Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 & 12 CH ECGCB Series S/WVASOMEDICAL, INC.DSH00817980020139
Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 5 Lead Patient CableModel 1303 KitVASOMEDICAL, INC.DSH00817980020399