Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System

System, Imaging, Pulsed Doppler, Ultrasonic

Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI)

The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (siui) with the FDA for Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System.

Pre-market Notification Details

Device IDK173000
510k NumberK173000
Device Name:Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou,  CN 515041
ContactFlower Cai
CorrespondentFlower Cai
Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou,  CN 515041
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-27
Decision Date2017-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06938396495084 K173000 000
06938396423001 K173000 000
06938396490256 K173000 000
06938396491291 K173000 000
06938396491307 K173000 000
06938396491321 K173000 000
06938396492250 K173000 000
06938396493288 K173000 000
06938396493295 K173000 000
06938396493301 K173000 000
06938396494049 K173000 000
06938396421007 K173000 000

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