K200203 is an FDA 510(k) clearance for the Infrascanner. 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 Cleared decision on July 10, 2020, 164 days after receiving the submission on January 28, 2020.
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 | K200203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2020 |
| Decision Date | July 10, 2020 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |