Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G 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 1000/ Apogee 1000neo/ Apogee 1000lite/ Apogee 1000exp/ Apogee 1000b/w / Apogee 1u/ Apogee 1t/ Apogee 1g Digital Color Doppler Ultrasound Imaging System.

Pre-market Notification Details

Device IDK210317
510k NumberK210317
Device Name:Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G 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 Date2021-08-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06938396494070 K210317 000
06938396491338 K210317 000
06938396410094 K210317 000
06938396410087 K210317 000
06938396410070 K210317 000
06938396410056 K210317 000
06938396400132 K210317 000
06938396400118 K210317 000
06938396400125 K210317 000

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