FDA.reportPublic FDA data

agelh

Primary DI
06973826010710
Brand
agelh
Company
DONGGUAN E-TEST TECHNOLOGY CO.,LTD
Model
BW-603
Published
2020-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193628000AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd.2020-07-12DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973826010717PackageGS136In Commercial Distribution
06973826010710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697382601071716973826010717
06973826010710069738260107106973826010710

GMDN Terms#

Term, Definition table
TermDefinition
Somatosensory evoked-potential graphic recorderAn electronic device designed to record an electrical potential that originates in the somatosensory pathway of the brain in response to somatosensory stimuli (e.g., an electrical or tactile stimulus on a part of the body). It is typically used as a component of a somatosensory evoked-potential graphic recording system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554511666
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973826010574agelhBA-803X2020-12-18
06973826010581agelhBA-805X2020-12-18
06973826010598agelhBA-806X2020-12-18
06973826010604agelhBA-811X2020-12-18
06973826010611agelhBA-812X2020-12-18
06973826010628agelhBA-813X2020-12-18
06973826010635agelhBA-821X2020-12-18
06973826010642agelhBA-822X2020-12-18
06973826010659agelhBA-823X2020-12-18
06973826010666agelhBA-826X2020-12-18
06973826010673agelhBA-8182020-12-18
06973826010680agelhBA-8192020-12-18
06973826010550agelhBA-801X2020-12-17
06973826010567agelhBA-802X2020-12-17
06973826010000agelhBT-3012020-12-18
06973826010017agelhBT-3022020-12-18
06973826010475agelhBT-3032020-12-18
06973826010482agelhBT-3052020-12-18
06973826010499agelhBT-3062020-12-18
06973826010505agelhBT-3082020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
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
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
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
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01