510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033645Substantially Equivalent

Otoflex 100 Tye 1012

Natus Medical Denmark ApS, Taastrup, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033645 is the FDA 510(k) clearance record for OTOFLEX 100 TYE 1012, a class II device, cleared for Gn Otometrics A/S on under FDA product code ETY (Tester, Auditory Impedance). FDA records list 15 510(k) clearances for Natus Medical Denmark ApS, from to . As of , FDA records show no recalls naming K033645.

Clearance record

Decision date
Received
(132 days to decision)
Product code
ETY Tester, Auditory Impedance
Regulation
21 CFR 874.1090
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Gn Otometrics A/S Dybendalsvaenget 2, Taastrup, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ETY

Trailing 12 months

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

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