Neurological Test Kit
The Neurological Test Kit is a neurology convenience kit containing instruments and accessories used for performing clinical neurological examinations, such as reflex hammers, tuning forks, and other standard neurological assessment tools. Product code PVP is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. It is classified as FDA Class I under regulation 21 CFR 882.1750, subject to general controls only. It falls under the Neurology medical specialty and is not flagged as an implant or life-sustaining device.
Research product code PVP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PVP
- Device Class
- FDA class 1
- Regulation Number
- 882.1750
- 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 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.