ATCOR MEDICAL PTY LTD

Address:301/55 Lime Street,SYDNEY New South Wales,AU

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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

Computer, Blood-Pressure (DSK) (2) Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (DRT) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1)

Premarket Exempt

Clear

SphygmoCor - 19351315000017 Catalog Number :

Device Description : Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct M Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others].CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL:• CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only].• CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)]• CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].

Device Class :

Duns Number: 751626706

Premarket Exempt : No

Product Code : DRT, DSK

Prescription Use : Yes

Device Count : 1

SphygmoCor - 19351315000031 Catalog Number :

Device Description : Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct M Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power cord/adapter, BP cuffs, and others).CONFIGURATIONS ENCOMPASSED BY THE XCEL VERSION/MODEL:• XCEL-PWA Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only].• XCEL-PWV Configuration: [SphygmoCor software configured for pulse wave velocity (PWV) only].• XCEL-PWA+PWV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)].

Device Class :

Duns Number: 751626706

Premarket Exempt : No

Product Code : DSK, DXN

Prescription Use : Yes

Device Count : 1

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