DeviceClearance

Product code SCP— Neurology

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Classification name
Computerized Behavioral Therapy Device For Anxiety Disorders
Device class
Class 2
Regulation
21 CFR 882.5801
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Computerized behavioral therapy device for psychiatric disorders”

— U.S. Food and Drug Administration, device classification record for product code SCP under 21 CFR 882.5801, via openFDA

Market context for product code SCP

FDA has cleared 1 device under product code SCP, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SCP

Recent clearances under product code SCP

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