BSD3543 Digital Flat Panel X-ray Detector— 510(k) K162487

Substantially Equivalent

Bontech, Inc.

FDA 510(k) clearance K162487 for BSD3543 Digital Flat Panel X-ray Detector, Substantially Equivalent on 2016-10-14. Applicant: Bontech, Inc..

Clearance details

Applicant: Bontech, Inc.
Product code: Code MQB
Advisory panel: Radiology
Date received: 2016-09-07
Decision date: 2016-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Suwon-Si, KR

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