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) (9) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (1)

Premarket Exempt

Yes No

Clear

Norav 1200 Series PC-ECG - 07290110250256 Catalog Number : 1200T3-K-00-U-C3-06

Device Description : Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110250249) and selectable cha Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110250249) and selectable channel, 5V operating voltage. Input Cable with 3 Patient Leads AHA Type and Clip ConnectorsSpecial edition for GE Health Care (IGEA)

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250263 Catalog Number : 1200T2-D-00-01

Device Description : PC-ECG Acquisition Device with Trigger, 5V

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250324 Catalog Number : 1200T2-D-00-02

Device Description : PC-ECG Acquisition Device with Trigger, 5V operating voltage, VENTRI GESpecial e PC-ECG Acquisition Device with Trigger, 5V operating voltage, VENTRI 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 - 07290110250409 Catalog Number : 1200T3-K-00-02

Device Description : Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110255053), 5V operating volt Kit includes: PC-ECG 1200T with Trigger (UDI: 07290110255053), 5V operating voltage, MGSpecial edition for Mediguide

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

WIRELESS ECG includes PC based receiver, Trigger out and detachable lead set - 07290110250485 Catalog Number :

Device Description : The PCECG 1200W System is comprised of wireless ECG recording box, which is base The PCECG 1200W System is comprised of wireless ECG recording box, which is based on an approved hardware, a RF receiver box connected to the computer and an ECG test software application. The intended user (patient) of the device is a subject that is referred to a rest (Stress) test for ischemic heart disease assessmentECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value

Device Class : 2

Duns Number: 514773159

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250522 Catalog Number : 1200W2-D-00E-01

Device Description : PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC 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 - 07290110250539 Catalog Number : 1200W2-D-01E-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 COSMED

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250546 Catalog Number : 1200W2-D-01U-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 COSMED

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250553 Catalog Number : 1200W2-D-02E-01

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110250560 Catalog Number : 1200W2-D-02U-01

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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