Device, Skin Potential Measurement
The Skin Potential Measurement Device is a neurological diagnostic instrument that measures the electrical potential differences at the skin surface, reflecting autonomic nervous system activity through changes in sweat gland secretion, used in research and clinical assessment of sudomotor function. It is classified as a Class 2 device (moderate risk). The product code is HCJ under regulation 21 CFR 882.1560 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HCJ
- Device Class
- FDA class 2
- Regulation Number
- 882.1560
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.