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™ 1305 3 Channel ECG Holter Recorder - 00817980020009 Catalog Number : A10-0083

Device Description : 3 CH ECG Holter Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter Recorder - 00817980020016 Catalog Number : A10-1307-01

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

Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder - 00817980020023 Catalog Number : A10-0082

Device Description : 12 CH ECG Holter Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder - 00817980020030 Catalog Number : A10-1308-01

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™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W - 00817980020047 Catalog Number : A10-0088

Device Description : Ambulatory Blood Pressure Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W - 00817980020054 Catalog Number : A10-1806-01

Device Description : Ambulatory Blood Pressure Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth - 00817980020061 Catalog Number : A10-1807-01

Device Description : Ambulatory Blood Pressure Recorder w/Bluetooth

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor - 00817980020078 Catalog Number : A10-0085

Device Description : 3 CH ECG Holter/ABP COMBINED Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 2302 Combined 12 Channel ECG Holter & ABP Monitor - 00817980020085 Catalog Number : A10-0086

Device Description : 12 CH ECG Holter/ABP COMBINED Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP Monitor - 00817980020092 Catalog Number : A10-2303-01

Device Description : 3 CH ECG Holter/ABP COMBINED Recorder

Device Class : 2

Duns Number: 197210248

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

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