FDA.reportPublic FDA data

CARDIOVIT CS-200 Excellence

Primary DI
07613365001105
Brand
CARDIOVIT CS-200 Excellence
Company
Schiller AG
Model
3.920280
Catalog number
3.920280
Device description
The CARDIOVIT CS-200 Excellence is a multichannel ECG device used for the recording, analysis and evaluation of ECG recordings. It is designed for indoor use and can be used for all patients of both sexes, all races, and all ages and is intended for use in hospitals, cardiologic units, out-patient clinical units, and general physicians offices.The diagnostic applications for which the CARDIOVIT CS-200 Excellence is intended is in the field of cardiac abnormalities in the general population, detecting acute myocardial ischemia, and infarction in chest pain patients.
Published
2023-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970879000CARDIOVIT CS-200Schiller America, Inc.1997-06-25LOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613365001105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365001105076133650011057613365001105

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41417664242info@schiller.ch

Regulatory Flags#

DUNS number
480868538
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613365003925SCHILLERECG D-SUB2 C 4.6/4.25 x10 IEC2.4001842026-05-26
07613365003932SCHILLERECG D-SUB2 C 4.6/4.25 x10 AHA2.4001852026-05-26
07613365003949SCHILLERECG D-SUB2 B 3.1/2.55 x10 IEC2.4001862026-05-26
07613365003956SCHILLERECG D-SUB2 B 3.1/2.55 x10 AHA2.4001872026-05-26
07613365004199SCHILLERECG D-SUB2 C 3.5/3.1 x14 IEC2.4003332026-05-26
07613365004205SCHILLERECG D-SUB2 C 3.5/3.1 x14 AHA2.4003342026-05-26
07613365004212SCHILLERECG D-SUB2 B 3.5/3.1 x14 IEC2.4003352026-05-26
07613365004229SCHILLERECG D-SUB2 B 3.5/3.1 x14 AHA2.4003362026-05-26
07613365004359ARGUS PB-3000PB-3000 Var.10, sub-variant: M/I3.9210332025-08-19
07613365000085ARGUS® PB-10003.9209483.9209482016-09-18
07613365000092ARGUS® PB-10003.9209783.9209782016-09-18
07613365004168ARGUS PB-3000PB-3000 Var.9, sub-variant: LB3.9210322025-08-19
07613365000122SCHILLERBP-200 plus3.9303002023-03-01
07613365000139SCHILLERBP-200 plus3.9303012023-03-01
07613365000245Schiller ECG patient cable2.4001392.4001392023-06-06
07613365002874Schiller ECG patient cable2.4001422.4001422023-06-06
07613365003208Schiller ECG patient cable2.4001402.4001402023-06-06
07613365003215Schiller ECG patient cable2.4001412.4001412023-06-06
07613365002218Schiller ECG patient cable2.4001782.4001782021-11-08
07613365002225Schiller ECG patient cable2.4001792.4001792021-11-08

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