BT-1000
K-Number: K232991 · 2024-08-28
ApplicantBistos Co., Ltd.
Decision Date2024-08-28
Product CodeQGL
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BT-1000 is a medical device manufactured by Bistos Co., Ltd.. It received FDA 510(k) clearance on 2024-08-28 under approval number K232991. The device is classified under product code QGL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BT-1000?
BT-1000 is a medical device that received FDA 510(k) clearance on 2024-08-28. It is manufactured by Bistos Co., Ltd.. The 510(k) number is K232991.
When was BT-1000 approved by the FDA?
BT-1000 received FDA 510(k) clearance on 2024-08-28, under approval number K232991.
What company makes BT-1000?
BT-1000 is manufactured by Bistos Co., Ltd..
What is the FDA product code for BT-1000?
The FDA product code for BT-1000 is QGL.
Other Devices by Bistos Co., Ltd.
Related Devices (Code: QGL)
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.