510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011135Substantially Equivalent

Gsi Audera

Nicolet Biomedical, Inc., Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011135 is the FDA 510(k) clearance record for GSI AUDERA, a class II device, cleared for Nicolet Biomedical on under FDA product code EWO (Audiometer). FDA records list 18 510(k) clearances for Nicolet Biomedical, from to . As of , FDA records show one recall naming K011135.

Clearance record

Decision date
Received
(104 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Nicolet Biomedical 6355 Joyce Dr., Golden CO
510(k) summary
Statement
Third party review
No

Clearances, product code EWO

Trailing 12 months

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

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