Neurological Tray
The Neurological Tray is a convenience kit packaging instruments and supplies used for neurological examination or procedures, such as reflex hammers, tuning forks, and sensory testing tools. Classified as FDA Class 1 under regulation 21 CFR 882.4525 within the Neurology medical specialty, it is subject to general controls only and is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, requiring no 510(k) submission when all criteria are met. The product code is OJG. It is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- OJG
- Device Class
- FDA class 1
- Regulation Number
- 882.4525
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.