Infrared Hematoma Detector

InfraScan, Inc.

The following data is part of a premarket notification filed by Infrascan, Inc. with the FDA for Infrascanner.

Pre-market Notification Details

Device IDK200203
510k NumberK200203
Device Name:Infrascanner
ClassificationInfrared Hematoma Detector
Applicant InfraScan, Inc. 3508 Market Street Philadelphia,  PA  19104
ContactBaruch Ben Dor
CorrespondentAngela Mallery
NAMSA 400 US-169 Minneapolis,  MN  55441
Product CodeOPT  
CFR Regulation Number882.1935 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-28
Decision Date2020-07-10

© 2020
This site is not affiliated with or endorsed by the FDA.