DeviceClearance

Product code PEQ— General Hospital

DERMA HOOD

Classification name
Accessories To Examination Light
Device class
Class 1
Regulation
21 CFR 880.6320
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.”

— U.S. Food and Drug Administration, device classification record for product code PEQ under 21 CFR 880.6320, via openFDA

Market context for product code PEQ

FDA has cleared 1 device under product code PEQ, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PEQ

Recent clearances under product code PEQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.