INFRASCANNER

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 IDK120949
510k NumberK120949
Device Name:INFRASCANNER
ClassificationInfrared Hematoma Detector
Applicant INFRASCAN, INC. 1835 MARKET ST., 29TH FLOOR Philadelphia,  PA  19103
ContactSteven B Datlof, M.d., J.d.
CorrespondentSteven B Datlof, M.d., J.d.
INFRASCAN, INC. 1835 MARKET ST., 29TH FLOOR Philadelphia,  PA  19103
Product CodeOPT  
CFR Regulation Number882.1935 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-30
Decision Date2013-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00861606000302 K120949 000

Trademark Results [INFRASCANNER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INFRASCANNER
INFRASCANNER
85767823 4357918 Live/Registered
InfraScan, Inc.
2012-10-31

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