MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT.

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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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (3)

Premarket Exempt

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Meditech - 05999056500044 Catalog Number : -

Device Description : The Meditech ABPM-04 Ambulatory Blood Pressure Monitor automatically measures th The Meditech ABPM-04 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

Device Class : 2

Duns Number: 401235817

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

Meditech - 05999056500051 Catalog Number : -

Device Description : The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures th The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

Device Class : 2

Duns Number: 401235817

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

Meditech - 05999056500068 Catalog Number :

Device Description : The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measu The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolicarterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standardoscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software.The device is intended for use with the standard indications and contraindications for ambulatory blood pressuremonitoring.

Device Class : 2

Duns Number: 401235817

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

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