Platform treatment system
K-Number: K203395 · 2022-01-28
Decision Date2022-01-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Platform treatment system is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-28 under approval number K203395. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Platform treatment system?
Platform treatment system is a medical device that received FDA 510(k) clearance on 2022-01-28. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K203395.
When was Platform treatment system approved by the FDA?
Platform treatment system received FDA 510(k) clearance on 2022-01-28, under approval number K203395.
What company makes Platform treatment system?
Platform treatment system is manufactured by Shanghai Apolo Medical Technology Co., Ltd..
What is the FDA product code for Platform treatment system?
The FDA product code for Platform treatment system is GEX. This falls under the Gastroenterology category.
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Official Source
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