510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823194Substantially Equivalent

Skin Galvanometer

Spelson Research Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823194 is the FDA 510(k) clearance record for SKIN GALVANOMETER, a class II device, cleared for Spelson Research Laboratories, Inc. on under FDA product code HCJ (Device, Skin Potential Measurement). FDA records list one 510(k) clearance for Spelson Research Laboratories, Inc. As of , FDA records show no recalls naming K823194.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HCJ Device, Skin Potential Measurement
Regulation
21 CFR 882.1560
Device class
Class II
Review panel
Neurology
Applicant
Spelson Research Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HCJ

Trailing 12 months

FDA records hold no clearances under product code HCJ in the trailing twelve months.

FDA records show no clearances under product code HCJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260