FDA.reportPublic FDA data

CARDIOVIT AT-180

Primary DI
07613365002775
Brand
CARDIOVIT AT-180
Company
Schiller AG
Model
3.920570
Device description
The CARDIOVIT AT-180 is an electrocardiograph intended to be used by trained operators under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis of cardiovascular diseases in adult and paediatric patients at rest.
Published
2023-10-09
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
K183425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183425000CARDIOVIT AT-102 G2Schiller AG2020-03-02DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613365002775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365002775076133650027757613365002775

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.

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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