Apogee 6500,Apogee 6300,Apogee 6200 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 6500,apogee 6300,apogee 6200 Digital Color Doppler Ultrasound Imaging System.

Pre-market Notification Details

Device IDK210318
510k NumberK210318
Device Name:Apogee 6500,Apogee 6300,Apogee 6200 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 Received2021-02-03
Decision Date2021-08-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06938396494063 K210318 000
06938396493219 K210318 000
06938396465001 K210318 000
06938396463007 K210318 000
06938396462000 K210318 000

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