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.. Device class: 2.

Clearance details

Applicant: Bistos Co., Ltd.
Product code: Code QGL
Device class: Class 2
Regulation: 21 CFR 882.5898
Advisory panel: Neurology
Date received: 2023-09-22
Decision date: 2024-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Bistos Co., Ltd.

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K160274 — Hi bebe plus2016-09-01
K142799 — Model BT-220L and BT-220C2015-07-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.