FDA.reportPublic FDA data

MasterScope

Primary DI
04057155000030
Brand
MasterScope
Company
eResearchTechnology GmbH
Model
MasterScope CT with ECG
Device description
diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
Published
2016-07-29
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
BTYCalculator, Predicted Values, Pulmonary Function
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082539000MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CTCardinal Health Germany 234 GmbH2008-12-02BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057155000030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057155000030040571550000304057155000030

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel electrocardiograph, signal-averagingAn instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple electrode sets (leads) simultaneously to simplify and facilitate interpretation of the record by enabling the comparison of multiple-lead recording of the same heartbeat. It is noninterpretive and reduces signal noise level by performing an average of multiple cycles of the signal; it may be used to detect late potentials for the identification of patients prone to ventricular tachycardia.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1800 7049698CustomerCare@ert.com
+1 908 5952020CustomerCare@clario.com
+4993057209891CustomerCare@clario.com

Regulatory Flags#

DUNS number
341625331
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057155000924SpiroWaySpiroWay2026-08-14
04057155000948ERT PTERT PT2025-08-11
04057155000955ERT PTERT PT2025-08-11
04057155000825SpiroSphereSpiroSphere Main Unit7074072024-12-03
04057155000801SpiroWaySpiroWay2024-07-22
04057155000580SpiroSphereSpiroSphere ECG2024-07-22
04057155000597SpiroSphereCardioSphere2024-07-22
04057155000665SpiroSphereSpiroSphere ECG CT2024-07-22
04057155000672SpiroSphereCardioSphere CT2024-07-22
04057155000689SpiroSphereSpiroSphere Standard ECG2024-07-22
04057155000696SpiroSphereCardioSphere Standard2024-07-22
04057155000795iSpiro Ultrasonic SensoriSpiro Ultrasonic Sensor2024-07-22
04057155000818SpiroWaySpiroWay2024-07-22
04057155000177Asthma Monitor AM1+AM1+2016-07-15
04057155000412ERT PTERT PT2019-02-25
04057155000771SpiroSphereSpiroSphere Main Unit7074062022-12-19
04057155000788SpiroSphereSpiroSphere CT1513132022-12-19
04057155000337RotationsflowgeberRotationsflowgeber2019-07-22
04057155000719SpiroSphereSpiroSphere Main Unit2021-02-18
04057155000726SpiroSphereSpiroSphere CT2021-02-18

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Primary DI, Brand, Company table
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00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
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06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
06944413847422SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
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