DemarkQ WOW, DemarkQ POP
K-Number: K203214 · 2021-07-22
ApplicantShenzhen Kaiyan Medical CO , Ltd.
Decision Date2021-07-22
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DemarkQ WOW, DemarkQ POP is a medical device manufactured by Shenzhen Kaiyan Medical CO , Ltd.. It received FDA 510(k) clearance on 2021-07-22 under approval number K203214. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DemarkQ WOW, DemarkQ POP?
DemarkQ WOW, DemarkQ POP is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Shenzhen Kaiyan Medical CO , Ltd.. The 510(k) number is K203214.
When was DemarkQ WOW, DemarkQ POP approved by the FDA?
DemarkQ WOW, DemarkQ POP received FDA 510(k) clearance on 2021-07-22, under approval number K203214.
What company makes DemarkQ WOW, DemarkQ POP?
DemarkQ WOW, DemarkQ POP is manufactured by Shenzhen Kaiyan Medical CO , Ltd..
What is the FDA product code for DemarkQ WOW, DemarkQ POP?
The FDA product code for DemarkQ WOW, DemarkQ POP is OLP.
Other Devices by Shenzhen Kaiyan Medical CO , Ltd.
Related Devices (Code: OLP)
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.