FDA.reportPublic FDA data

Delica

Primary DI
06970481940109
Brand
Delica
Company
Shenzhen Delica Medical Equipment Co., Ltd.
Model
EMS-9D EXP
Published
2019-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXQBlood Pressure Cuff
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
OQQDiagnostic Ultrasonic Transducer, Robotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
DXQBlood Pressure CuffCardiovascular2
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
OQQDiagnostic Ultrasonic Transducer, RoboticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190228000Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.2019-06-13IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970481940109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970481940109069704819401096970481940109

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544412009
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970481940093DelicaEMS-9D PRO2019-06-20
06970481940031DelicaEMS-9UA2016-09-19
06970481940048DelicaEMS-9PB2016-09-19
06970481940017DelicaEMS-9U12023-06-21
06970481940024DelicaEMS-9U22023-06-21
06970481940161DelicaEMS-9M22022-07-25
06970481940178DelicaEMS-9M12022-07-25
06970481940079DelicaEMS-9D2018-07-17
06970481940086DelicaEMS-9F2018-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08683255231881GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIITX2026-10-27
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYN2026-10-26
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.ITX2026-10-26
07070554100863Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100870Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100887Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100894Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100900Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
00850018318051AI PlatformExo Imaging, Inc.IYN2026-10-22
03770033463055FETOLYDIAGNOLYIYN2026-10-22
00850070979405FondCircleFondCircle Inc.DXN2026-10-21
00850070979412FondCircleFondCircle Inc.DXN2026-10-21
08719327007136FinapresFinapres Medical Systems B.V.DXN2026-10-21
04719873000524InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-05-04
04719873000524InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-05-04
04719873000517InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONITX2021-12-14
04719873000517InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2021-12-14
04719873000319InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONITX2021-09-24
04719873000319InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2021-09-24
04719873000258InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONITX2019-09-23
04719873000258InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2019-09-23
04719873000333InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONITX2019-09-23
04719873000333InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2019-09-23
04719873009183C83B TransducerQISDA CORPORATIONITX2019-09-23
04719873000265InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONITX2019-03-09
04719873000265InnoSight Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2019-03-09
06940211627693MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627709MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627969MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628010MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31