Product code HCJ— Neurology

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Classification name
Device, Skin Potential Measurement
Device class
Class 2
Regulation
21 CFR 882.1560
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

Market context for product code HCJ

FDA has cleared 2 devices under product code HCJ, all in 1983, filed by 2 applicant companies. 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 HCJ

Recent clearances under product code HCJ

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