DeepBT Detector-Plus
K-Number: K252190 · 2026-04-10
ApplicantAitewan Biomedical Technology, Inc.
Decision Date2026-04-10
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DeepBT Detector-Plus is a medical device manufactured by Aitewan Biomedical Technology, Inc.. It received FDA 510(k) clearance on 2026-04-10 under approval number K252190. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DeepBT Detector-Plus?
DeepBT Detector-Plus is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Aitewan Biomedical Technology, Inc.. The 510(k) number is K252190.
When was DeepBT Detector-Plus approved by the FDA?
DeepBT Detector-Plus received FDA 510(k) clearance on 2026-04-10, under approval number K252190.
What company makes DeepBT Detector-Plus?
DeepBT Detector-Plus is manufactured by Aitewan Biomedical Technology, Inc..
What is the FDA product code for DeepBT Detector-Plus?
The FDA product code for DeepBT Detector-Plus is QKB.
Related Devices (Code: QKB)
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.