Definition: To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas.
Device Type ID | 3811 |
Device Name | Infrared Hematoma Detector |
Physical State | This Is A Standard Infrared Handheld Laser That Is Scanned Across The Scalp. The Information Is Transmitted To A Handheld Personal Digital Assistant That Displays Optical Density Measurements |
Technical Method | Use Of Low Level Infrared Laser Radiation To Detect Hemoglobin Concentration Which Relates To Presence Of A Hemotoma. |
Target Area | To Be Used On The Head. The Testing Divides The Head Into 8 Sections Four On The Left Side And The Corresponding 4 Sites On The Right Side. |
Regulation Description | Near Infrared (NIR) Brain Hematoma Detector. |
Regulation Medical Specialty | Ophthalmic |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
Submission Type | 510(k) |
CFR Regulation Number | 882.1935 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | OPT |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3811 |
Device | Infrared Hematoma Detector |
Product Code | OPT |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Near Infrared (NIR) Brain Hematoma Detector. |
CFR Regulation Number | 882.1935 [🔎] |