Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System
K-Number: K160853 · 2016-06-27
Decision Date2016-06-27
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System is a medical device manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2016-06-27 under approval number K160853. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System?
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2016-06-27. It is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K160853.
When was Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System approved by the FDA?
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System received FDA 510(k) clearance on 2016-06-27, under approval number K160853.
What company makes Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System?
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui).
What is the FDA product code for Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System?
The FDA product code for Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System is IYN.
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Other Devices by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
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K200637SR-8100 Portable X-ray Unit
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K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.