NORAV MEDICAL LTD.

Address:4 HAMADA ST.,YOKNEAM Northern,IL

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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

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (8) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (2)

Premarket Exempt

No Yes

Clear

Norav 1200 Series PC-ECG - 07290110250027 Catalog Number : 1200T2-K-00-U-C3-02

Device Description : Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110250324), 5V operating volt Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110250324), 5V operating voltage, FW7 GE Input Cable with 3 Patient Leads AHA Type and Clip ConnectorsSpecial edition for GE Health Care

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250089 Catalog Number : 1200T2-K-00-U-C3-03

Device Description : Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110250119), 5V operating volt Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110250119), 5V operating voltage, FW7, Tandem, GE Input cable with three leads AHA type and Clip connectors.Special edition for Mediguide

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250119 Catalog Number : 1200T2-D-00-05

Device Description : PC-ECG Acquisition Device with Trigger, 5V operating voltage, D630, TANDEM, GESp PC-ECG Acquisition Device with Trigger, 5V operating voltage, D630, TANDEM, GESpecial edition for GE Health Care

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250140 Catalog Number : 1200W2-D-04E-01

Device Description : PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labellingSp PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labellingSpecial edition for GE Health Care

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250157 Catalog Number : 1200W2-D-04U-01

Device Description : PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labellingSp PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labellingSpecial edition for GE Health Care

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250188 Catalog Number : 1200HRT-K-01-U-S10-01

Device Description : Kit includes: PC-ECG 1200HR (UDI: 07290110252939) for High Resolution Resting-EC Kit includes: PC-ECG 1200HR (UDI: 07290110252939) for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG Trigger Output and AHA type labelling. Input cable with 10 Patient leads AHA type and Snap connectors.Special edition for COSMED

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250195 Catalog Number : 1200W2-K-00-E-S10-01

Device Description : Kit includes: PC-ECG 1200W (UDI: 07290110250522) wireless Stress-Test Kit Kit includes: PC-ECG 1200W (UDI: 07290110250522) wireless Stress-Test Kit Input cable with ten leads IEC type and Snap connectors.

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250225 Catalog Number : ECGUSB1DEX-K-00-UC3-04

Device Description : Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110254285) fo Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110254285) for integration in other Medical Devices; Input cable with three Patient Leads AHA type with Clip connectors.Special edition for GE Health Care.

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : No

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250232 Catalog Number : ECGUSB1DEX-K-00-EC3-04

Device Description : Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110254285) fo Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110254285) for integration in other Medical Devices; Input cable with three Patient Leads IEC type with Clip connectors.Special edition for GE Health Care.

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : No

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250249 Catalog Number : 1200T3-D-00-04

Device Description : PC-ECG Acquisition Device with Trigger and selectable channel, 5V operating volt PC-ECG Acquisition Device with Trigger and selectable channel, 5V operating voltage.Special edition for GE Health Care (IGEA)

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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