BSD3543W— 510(k) K200787

Substantially Equivalent

Bontech Co., Ltd.

FDA 510(k) clearance K200787 for BSD3543W, Substantially Equivalent on 2020-04-23. Applicant: Bontech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bontech Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-03-26
Decision date: 2020-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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