510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K092111Substantially Equivalent

Entomed Screening Audiometer, Model Sa201,sa202, Entomed Diagnostic Audiometer Model Sa203,sa204

Entomed AB, Malmo, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092111 is the FDA 510(k) clearance record for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204, a class II device, cleared for Entomed AB on under FDA product code EWO (Audiometer). FDA records list one 510(k) clearance for Entomed AB. As of , FDA records show no recalls naming K092111.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Entomed AB Bariumgatan 29, Malmo, SE
510(k) summary
Summary PDF
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