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510(k) K211617

Device
Infrascanner
Applicant
Infrascan, Inc.
510(k) number
K211617
Product code
OPT  
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-09
Date received
2021-05-26
Regulation
882.1935
Classification name
Infrared Hematoma Detector
Medical specialty
Ophthalmic
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Baruch Ben Dor
Address
3508 Market St. Philadelphia PA US 19104 19104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OPT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241389Infrascanner Model 2500 (Model 2500)Infrascan, Inc.2024-12-12
K200203InfrascannerInfrascan, Inc.2020-07-10
K120949INFRASCANNERInfrascan, Inc.2013-01-11
DEN100002INFRASCANNER, MODEL 1000Infrascan, Inc.2011-12-13

Legacy Summary#

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FDA Review#

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