BSD4343 Digital Flat Panel X-ray Detector— 510(k) K160204

Name: FDA 510(k) clearance K160204
Creator: U.S. Food and Drug Administration
Published: 2016-06-09

Substantially Equivalent

Bontech, Inc.

FDA 510(k) clearance K160204 for BSD4343 Digital Flat Panel X-ray Detector, Substantially Equivalent on 2016-06-09. Applicant: Bontech, Inc.. Device class: 2.

Clearance details

Applicant: Bontech, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2016-01-28
Decision date: 2016-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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