INFRASCANNER, MODEL 1000

Infrared Hematoma Detector

INFRASCAN, INC.

The following data is part of a De Novo classification by Infrascan, Inc. with the FDA for Infrascanner, Model 1000.

Pre-market Notification Details

DeNovo IDDEN100002
Device Name:INFRASCANNER, MODEL 1000
ClassificationInfrared Hematoma Detector
Applicant INFRASCAN, INC. 3508 Market St., Suite 215 Philadelphia,  PA  19104 -3320
ContactSteven B Datlof
Product CodeOPT  
CFR Regulation Number882.1935 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK080377
Review Advisory BoardNeurology
Classification AdvisoryOphthalmic
TypePost-NSE
Date Received2010-04-08
Decision Date2011-12-13
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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