510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821250Substantially Equivalent

Metraco Evoked Potential System

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

K821250 is the FDA 510(k) clearance record for METRACO EVOKED POTENTIAL SYSTEM, a class II device, cleared for Metraco, Inc. on under FDA product code GWL (Amplifier, Physiological Signal). FDA records list one 510(k) clearance for Metraco, Inc. As of , FDA records show no recalls naming K821250.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GWL Amplifier, Physiological Signal
Regulation
21 CFR 882.1835
Device class
Class II
Review panel
Neurology
Applicant
Metraco, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GWL

Trailing 12 months

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

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