FDA.reportPublic FDA data

"ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3"" prin"

Primary DI
07290110252519
Brand
"ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3"" prin"
Company
NORAV MEDICAL LTD.
Model
ECG-LAN (Green)
Catalog number
ECG-LAN-GREEN-K-00-01
Device description
"Mobile PC-ECG 1200 System for Resting-ECG, based on an All-in-One-PC with 21"" Touch Screen, rechargeable Battery and built-in ECG Acquisition Unit."
Published
2017-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000404000PC ECG 1200Norav Medical , Ltd.2000-11-22MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110252519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110252519072901102525197290110252519

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97249893001support@norav.com

Regulatory Flags#

DUNS number
514773159
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110255367Norav 1200 Series PC-ECG1200WR1200WR-D-00-072019-09-27
07290110250591Receiver for 1200W with ECG trigger (TTL) outputPCECG 1200WR1200WR-D-00-012016-10-26
07290110251192Telemetry System. License + Software for up to 7 usersNM-700BT2017-01-03
07290110255008Norav 1200 Series PC-ECGSW P-MP200HASP-SW-K-P1-012019-10-02
07290110252502Norav 1200 Series PC-ECGECGLAN Green PCLAN-GREEN-PC-012019-09-30
07290110251062ECG ECGUSB1D-EX-FW11/BECG Module2016-10-13
07290110255558Norav 1200 Series PC-ECGECGUSB1DEX KitECGUSB1DEX-K-00-UC3-082020-06-05
07290110255572Norav 1200 Series PC-ECGECGUSB1DEXECGUSB1DEX-D-00-102020-06-05
07290110255589Norav 1200 Series PC-ECGECGUSB1DEX KitECGUSB1DEX-K-00-EC3-102020-06-05
07290110255480Norav 1200 Series PC-ECG1200HRT Kit1200HRT-K-00-U-S10-032020-06-03
07290110255497Norav 1200 Series PC-ECG1200HRT1200HRT-D-00U-032020-06-03
07290110255411Norav 1200 Series PC-ECGSW I3HASP-SW-K-I3-012019-10-11
07290110252762Norav 1200 Series PC-ECGSW S1HASP-SW-K-S1-012019-10-02
07290110252779Norav 1200 Series PC-ECGSW S2HASP-SW-K-S2-012019-10-02
07290110252786Norav 1200 Series PC-ECGSW S2toS2HASP-SW-K-S2-S1-012019-10-02
07290110252793Norav 1200 Series PC-ECGSW S2-I1HASP-SW-K-S2I1-012019-10-02
07290110252809Norav 1200 Series PC-ECGSW S2-I1-D1HASP-SW-K-S2I1D1-012019-10-02
07290110252816Norav 1200 Series PC-ECGSW S2-I3-D1HASP-SW-K-S2I3D1-012019-10-02
07290110255022Norav 1200 Series PC-ECGSW S2-I2HASP-SW-K-S2I2-012019-10-02
07290110252601Norav 1200 Series PC-ECGSW S2-I2-D1HASP-SW-K-S2I2D1-012019-10-01

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