Biovitals Analytics Engine

Primary DI
08885018690021
Brand
Biovitals Analytics Engine
Company
BIOFOURMIS SINGAPORE PTE. LTD.
Model
2.0
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
PLBMultivariate Vital Signs Index

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLBMultivariate Vital Signs IndexCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183282000Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.2019-08-15PLB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885018690021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885018690021088850186900218885018690021

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system transceiverAn electrically-powered device intended to receive data relating to multiple vital physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)] from an appropriate sensor, and wirelessly transmit the data to a parent device (e.g., monitor and/or an off-the-shelf computer/tablet) with appropriate software installed; it may in addition be intended to provide electrical energy to the connected probe/electrode.

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
08885018690014RhythmAnalytics1.12022-10-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350140270027NAVOYCDSAlgoDx ABPLB2026-05-13
00863061000316T3 PLATFORM SOFTWAREETIOMETRY INC.PLB2026-03-17
00863061000323ETIOMETRY PLATFORMETIOMETRY INC.PLB2026-03-17
00850071330038prolaio Personalized Physiology Analytics Engine Software (PPA)Prolaio, Inc.PLB2025-06-13
08809957910002SpassageQSpass Co.,Ltd.PLB2023-06-27
00860004366263physIQ Personalized Physiology Analytics EnginePHYSIQ, INCPLB2022-01-10
00863061000309T3 Risk Analytics PlatformETIOMETRY INC.PLB2016-09-09