510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K011746Substantially Equivalent

Mb 11

Maico Diagnostic GmbH, Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011746 is the FDA 510(k) clearance record for MB 11, a class II device, cleared for Maico Diagnostic GmbH on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list one 510(k) clearance for Maico Diagnostic GmbH. As of , FDA records show no recalls naming K011746.

Clearance record

Decision date
Received
(79 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Maico Diagnostic GmbH 9675 W. 76th St., Eden Prairie MN
510(k) summary
Statement
Third party review
No

Clearances, product code GWJ

Trailing 12 months

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

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