Neo Medical

GUDID 04719890960283

neo Medical Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Peripheral Vessel, Carotid, Urology, FAST/EFAST, Lung, Ocular, Transcranial, Nerve, Bladder, Cardiac (Pediatric and Adult) and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, Power Doppler, PW Doppler and Combined (B+M; B+CD; B+PD) modes. Intended User Neo Medical Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. Neo Medical System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare

Aco Healthcare Co., Ltd.

Hand-held ultrasound imaging system, body-surface
Primary Device ID04719890960283
NIH Device Record Keya1a89988-8a74-4ac9-920f-6a5142954a1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo Medical
Version Model Numberneo P42
Company DUNS658742955
Company NameAco Healthcare Co., Ltd.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com
Phone408-278-9300
Emailservice@neomedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104719890960283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-17
Device Publish Date2024-09-09

On-Brand Devices [Neo Medical]

04719890960283neo Medical Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analy
04719890960276neo Medical Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analy
04719890960269neo L154
04719890960252Neo Medical Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analy

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