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) (4) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (4) Electrocardiograph, Ambulatory (Without Analysis) (MWJ) (2)

Premarket Exempt

Yes No

Clear

Norav 1200 Series PC-ECG - 07290110255121 Catalog Number : 1200HR-D-00U-05

Device Description : PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG re PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings with AHA type labelling.

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110255138 Catalog Number : 1200S-K-00-U-S10-06

Device Description : Kit includes: PC-ECG 1200M (UDI: 07290110250812) for Stress-Test ECG with AHA ty Kit includes: PC-ECG 1200M (UDI: 07290110250812) for Stress-Test ECG with AHA type labelling; Input Cable with 10 Patient Leads AHA Type and Snap Connectors.Special edition for Device Technologies Australia

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110255145 Catalog Number : ECGUSB1DEXR-K00-EC3-03

Device Description : Kit includes: Acquisition Module for 1 Channel ECG and 1 Channel Respiration (D Kit includes: Acquisition Module for 1 Channel ECG and 1 Channel Respiration (DI no.: 07290110253011) for integration in other Medical Devices; Input cable with three Patient Leads IEC type and Clip connectors.Special edition for SDK.

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : No

Device Count : 1

Norav 1200 Series PC-ECG - 07290110255152 Catalog Number : 1200M-K-00-U-B10-06

Device Description : Kit includes: PC-ECG 1200M (UDI: 07290110252854) for Resting-ECG with AHA type l Kit includes: PC-ECG 1200M (UDI: 07290110252854) for Resting-ECG with AHA type labelling; Input Cable with 10 Patient Leads AHA Type and Banana Connectors; Software option "I3" MEANS Interpretation.Special edition for Device Technologies Australia

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110255169 Catalog Number : 1200M-K-00-U-B10-07

Device Description : Kit includes: PC-ECG 1200M (UDI: 07290110252854) for Resting-ECG with AHA type l Kit includes: PC-ECG 1200M (UDI: 07290110252854) for Resting-ECG with AHA type labelling; Input Cable with 10 Patient Leads AHA Type and Banana Connectors; Software option "I2" Measurement & Interpretation.Special edition for Device Technologies Australia

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110255176 Catalog Number : ECGUSB1DEX-K-00-UC3-07

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 - 07290110255183 Catalog Number : ECGUSB1DEX-K-00-EC3-07

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 - 07290110255190 Catalog Number : 1200W2-K-00-U-S10-20

Device Description : Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Input cable with ten leads AHA type and Snap connectors.Special edition for TAISHO, Japan

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav NR Series - 07290110255206 Catalog Number : NR1207E-K-00-E-01

Device Description : Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling.Special edition for TASHIO

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Norav NR Series - 07290110255213 Catalog Number : NR12073-K-00-E-01

Device Description : Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) fo Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.Special edition for TASHIO

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

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