BT-1000
K-Number: K232991 · 2024-08-28
Device Summary
Frequently Asked Questions
What is the BT-1000?
BT-1000 is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K232991.
When did BT-1000 receive FDA 510(k) clearance?
BT-1000 received FDA 510(k) clearance on 2024-08-28, under 510(k) number K232991.
Who is the listed applicant for BT-1000?
The FDA 510(k) record lists Bistos Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BT-1000?
The FDA product code for BT-1000 is QGL.
Other records listing Bistos Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QGL)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.