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
00859140003200DealmedDEALMED MEDICAL SUPPLIES LLCDXQ2026-10-08
00859140003217DealmedDEALMED MEDICAL SUPPLIES LLCDXQ2026-10-08
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
04250413405657ABPMpro SoftwareSOMNOmedics AGDXN2026-10-07
10884450480615Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2026-10-07
00634782102357ADView® 2.6AMERICAN DIAGNOSTIC CORPDXN2026-10-06
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782102517ADCAMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00198953009567Carescape ONEGE Healthcare Finland OyDXN2026-10-04
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
00810226060166Easy@Home Blood Pressure MonitorEASY HEALTHCARE CORPORATIONDXN2026-09-30
06948423816218Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd.DXN2026-09-30
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYN2026-09-29
00093764604737A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
00093764604744A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYN2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
06953825911874AlphaMedShenzhen Urion Technology Co., LtdDXN2026-09-22
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953126073VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18