# Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector
> **Food and Drug Administration** · Final rule. · Published 2012-03-23 · Effective 2012-04-23 · 77 FR 16925
## Document
- **Document number:** 2012-6975
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 77 FR 16925
- **CFR reference:** 21 CFR 882
- **Publication date:** 2012-03-23
- **Effective date:** 2012-04-23
- **HHS docket:** Docket No. FDA-2012-M-0206
## Abstract

The Food and Drug Administration (FDA) is classifying the Near Infrared (NIR) Brain Hematoma Detector into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2012/03/23/2012-6975/medical-devices-neurological-devices-classification-of-the-near-infrared-brain-hematoma-detector)
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