BIOK7600W Wireless Flat Panel Detector

Solid State X-ray Imager (flat Panel/digital Imager)

Biokinemetrics Inc.

The following data is part of a premarket notification filed by Biokinemetrics Inc. with the FDA for Biok7600w Wireless Flat Panel Detector.

Pre-market Notification Details

Device IDK190300
510k NumberK190300
Device Name:BIOK7600W Wireless Flat Panel Detector
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Biokinemetrics Inc. 211 East 4th Street Carroll,  IA  51401
ContactSteven Kraus
CorrespondentSteven Kraus
Biokinemetrics Inc. 211 East 4th Street Carroll,  IA  51401
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-12
Decision Date2019-03-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.