DEN100002 is an FDA 510(k) submission for the INFRASCANNER, MODEL 1000. This device is classified as a Infrared Hematoma Detector (Class II - Special Controls, product code OPT).
Submitted by Infrascan, Inc. (Philadelphia, US). The FDA issued a Not Cleared (DENG) decision on December 13, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1935. To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas..
| 510(k) Number | DEN100002 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 08, 2010 |
| Decision Date | December 13, 2011 |
| Days to Decision | 614 days |
| Submission Type | Post-NSE |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | OPT - Infrared Hematoma Detector |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1935 |
| Definition | To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas. |