BIOK7600W Wireless Flat Panel Detector— 510(k) K190300

Name: FDA 510(k) clearance K190300
Creator: U.S. Food and Drug Administration
Published: 2019-03-13

Substantially Equivalent

Biokinemetrics, Inc.

FDA 510(k) clearance K190300 for BIOK7600W Wireless Flat Panel Detector, Substantially Equivalent on 2019-03-13. Applicant: Biokinemetrics, Inc.. Device class: 2.

Clearance details

Applicant: Biokinemetrics, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2019-02-12
Decision date: 2019-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carroll, IA, US

Download summary PDF View on FDA.gov ↗

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