ChecQ (AC100)
K-Number: K241065 · 2025-03-21
ApplicantDentis Co., Ltd.
Decision Date2025-03-21
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ChecQ (AC100) is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2025-03-21 under approval number K241065. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ChecQ (AC100)?
ChecQ (AC100) is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K241065.
When was ChecQ (AC100) approved by the FDA?
ChecQ (AC100) received FDA 510(k) clearance on 2025-03-21, under approval number K241065.
What company makes ChecQ (AC100)?
ChecQ (AC100) is manufactured by Dentis Co., Ltd..
What is the FDA product code for ChecQ (AC100)?
The FDA product code for ChecQ (AC100) is EKX.
Other Devices by Dentis Co., Ltd.
Related Devices (Code: EKX)
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.