Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector
fda-device · Food and Drug Administration · Rule · Published 2012-03-23 · Effective 2012-04-23 · 77 FR 16925
Document
Document number
2012-6975
Federal Register citation
77 FR 16925
CFR reference
21 CFR 882
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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.