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PSP — Intracranial Pressure & Temperature Monitoring Kit Class II

FDA Device Classification

FDA product code PSP covers "Intracranial Pressure & Temperature Monitoring Kit", a Class II medical device regulated under 21 CFR 882.1620. Submissions are reviewed by the Neurology panel.

Classification Details

Product Code
PSP
Device Class
Class II
Regulation Number
882.1620
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

FDA data resources