510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082035Substantially Equivalent

Maico Mb 11 with Beraphone Probe

MAICO Diagnostics GmbH, Minnesota MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K082035 is the FDA 510(k) clearance record for MAICO MB 11 WITH BERAPHONE PROBE, a class II device, cleared for Maico Diagnostics on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 5 510(k) clearances for Maico Diagnostics, from to . As of , FDA records show no recalls naming K082035.

Clearance record

Decision date
Received
(196 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Maico Diagnostics 7625 Golden Triangle Dr., Minnesota 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