VASOMEDICAL, INC.

Address:137 Commercial St Ste 200,Plainview,NY,11803,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

RECORDER, MAGNETIC TAPE, MEDICAL (DSH) (10)

Premarket Exempt

Clear

Vasomedical-Biox™ 2304 Combined 12 Channel ECG Holter & ABP Monitor - 00817980020108 Catalog Number : A10-2304-01

Device Description : 12 CH ECG Holter/ABP COMB Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 2305 Combined 3 CH ECG Holter & ABP Monitor with Bluetooth - 00817980020115 Catalog Number : A10-2305-01

Device Description : 3 CH ECG Holter/ABP COMB Recorder w/Bluetooth

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 2306 Combined 12 CH ECG Holter & ABP Monitor with Bluetooth - 00817980020122 Catalog Number : A10-2306-01

Device Description : 12 CH ECG Holter/ABP COMB Recorder w/Bluetooth

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 & 12 CH ECG - 00817980020139 Catalog Number : A10-0031

Device Description : CB Series Analysis & Reporting Software - 3 & 12 CH ECG

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG - 00817980020146 Catalog Number : A10-0032

Device Description : CB Series Analysis & Reporting Software - 3 CH ECG

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG & ABP - 00817980020153 Catalog Number : A10-0035

Device Description : CB Series Analysis & Reporting S/W - 3 CH ECG & Combined ABPM

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ CB Series Analysis & Reporting S/w - 3 & 12 CH ECG & ABP - 00817980020160 Catalog Number : A10-0036

Device Description : CB Series Analysis & Reporting S/W - 3 & 12 CH ECG & Combined ABPM

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ ARCS Analysis & Reporting S/W & Dongle, 3 CH ECG, USB - 00817980020177 Catalog Number : A10-0118-00

Device Description : ARCS Analysis & Reporting Software & Dongle, 3 Channel ECG, USB

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder - 00817980020184 Catalog Number : A10-1306-01

Device Description : 12 CH ECG Holter ULTRA Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 1303 Ultra Compact 3 Channel ECG Holter Recorder - 00817980020191 Catalog Number : A10-0087

Device Description : 3 CH ECG Holter ULTRA Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

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