510(k) DEN100002
DEN100002 is an FDA 510(k) premarket notification submitted by Infrascan, Inc. for the device "INFRASCANNER, MODEL 1000". The FDA issued a decision of De Novo Granted on December 13, 2011. The device falls under product code OPT (Infrared Hematoma Detector), a Class II device regulated under 21 CFR 882.1935. Infrascan, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 13, 2011
- Date Received
- April 8, 2010
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infrared Hematoma Detector
- Device Class
- Class II
- Regulation Number
- 882.1935
- Review Panel
- NE
- Submission Type
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.