§ 878.4165. Wound autofluorescence imaging device.
72 words·~1 min read·
/us/cfr/t21/s§ 878.4165·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. [83 FR 52968, Oct. 19, 2018]
Connections1 cite this
Cited by 1 section
register
Citation graph
cites case law
§ 878.4165
Wound autofluorescence imaging device.
Fed. Reg.×1
Cites 0Cited by 1 across 1 source