FDA.reportPublic FDA data

BP2 Blood Pressure Monitor

Primary DI
06934440102618
Brand
BP2 Blood Pressure Monitor
Company
Shenzhen Viatom Technology Co.,Ltd.
Model
BP2 Blood Pressure Monitor
Published
2024-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193348000Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.2020-06-25DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934440102618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934440102618069344401026186934440102618

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, home-useA device intended to be used by a layperson in the home 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 may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421357243
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934440102021VIATOM Pulse OximeterPO22025-11-12
06934440102977LEPU MEDICALPO22025-03-17
06934440103066Pulse OximeterPO22025-03-17
06934440103073Pulse OximeterPO2A2025-03-17
06934440103080Pulse OximeterPO2B2025-03-17
06934440102311ViatomPO6 Oxyfit Pulse Oximeter2023-12-12
06934440102069CheckmeBP2 Blood Pressure Monitor2024-12-24
06934440102212Wellue/ViatomBP2 Blood Pressure Monitor2024-12-24
06934440102588LEPU MEDICALBP2 Blood Pressure Monitor2024-12-24
06934440102748CheckmeBP2A Blood Pressure Monitor2024-12-24
06934440102755BP2A Blood Pressure MonitorBP2A Blood Pressure Monitor2024-12-24
06934440102762LEPU MEDICALBP2A Blood Pressure Monitor2024-12-24
06934440102809Pulse OximeterS92024-12-23
06934440102816Pulse OximeterS102024-12-23
06934440102823Pulse OximeterS112024-12-23
06934440102830Pulse OximeterS122024-12-23
06934440102847Pulse OximeterS132024-12-23
06934440102854Pulse OximeterS13B2024-12-23
06934440102861Pulse OximeterS142024-12-23
06934440102878Pulse OximeterS32024-12-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
00884838096745Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
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09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14