BT-1000— 510(k) K232991

Substantially Equivalent

Bistos Co., Ltd.

FDA 510(k) clearance K232991 for BT-1000, Substantially Equivalent on 2024-08-28. Applicant: Bistos Co., Ltd..

Clearance details

Applicant: Bistos Co., Ltd.
Product code: Code QGL
Advisory panel: Neurology
Date received: 2023-09-22
Decision date: 2024-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi, KR

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