The following data is part of a De Novo classification by Infrascan, Inc. with the FDA for Infrascanner, Model 1000.
DeNovo ID | DEN100002 |
Device Name: | INFRASCANNER, MODEL 1000 |
Classification | Infrared Hematoma Detector |
Applicant | INFRASCAN, INC. 3508 Market St., Suite 215 Philadelphia, PA 19104 -3320 |
Contact | Steven B Datlof |
Product Code | OPT |
CFR Regulation Number | 882.1935 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | K080377 |
Review Advisory Board | Neurology |
Classification Advisory | Ophthalmic |
Type | Post-NSE |
Date Received | 2010-04-08 |
Decision Date | 2011-12-13 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |