510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820040Substantially Equivalent

Sc-It Impedance Tester

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

K820040 is the FDA 510(k) clearance record for SC-IT IMPEDANCE TESTER, a class I device, cleared for Cadwell Laboratories, Inc. on under FDA product code GYA (Tester, Electrode/Lead, Electroencephalograph). FDA records list 46 510(k) clearances for Cadwell Laboratories, Inc., from to . As of , FDA records show no recalls naming K820040.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GYA Tester, Electrode/Lead, Electroencephalograph
Regulation
21 CFR 882.1410
Device class
Class I
Review panel
Neurology
Applicant
Cadwell Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GYA

Trailing 12 months

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

FDA records show no clearances under product code GYA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYA, 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