510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K913356Substantially Equivalent

The Monitor/demlar Model Mi-5000 Audiometer

Monitor Instruments, Inc., Chapel Hill NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913356 is the FDA 510(k) clearance record for THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER, a class II device, cleared for Monitor Instruments, Inc. on under FDA product code EWO (Audiometer). FDA records list 2 510(k) clearances for Monitor Instruments, Inc., from to . As of , FDA records show no recalls naming K913356.

Clearance record

Decision date
Received
(128 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Monitor Instruments, Inc. 605 Eastowne Dr., Chapel Hill NC
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