FDA.reportPublic FDA data

RhythmAnalytics

Primary DI
08885018690014
Brand
RhythmAnalytics
Company
BIOFOURMIS SINGAPORE PTE. LTD.
Model
1.1
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182344000RhythmAnalyticsBiofourmis Singapore Pte., Ltd.2019-03-07DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885018690014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885018690014088850186900148885018690014

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology application softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
659253421
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08885018690106Everion+ System Adjustable ArmbandEVR-PD-AAB2023-05-02
08885018690090Everion+ System Adjustable ArmbandEVR-PD-AAB2023-05-02
08885018690083Everion+ System Adjustable ArmbandEVR-PD-AAB2023-05-02
08885018690007Everion+ SystemEVRPLUS-G2023-03-22
08885018690021Biovitals Analytics Engine2.02022-10-28

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