510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K934342Substantially Equivalent

Glaser Rt450 Hearing Aid Test and Analysis System

Glaser Instruments AG, Switzerland, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934342 is the FDA 510(k) clearance record for GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM, a class II device, cleared for Glaser Instruments AG on under FDA product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems). FDA records list 2 510(k) clearances for Glaser Instruments AG. As of , FDA records show no recalls naming K934342.

Clearance record

Decision date
Received
(136 days to decision)
Product code
ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Regulation
21 CFR 874.3310
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Glaser Instruments AG Sihltalstrasse 74, Switzerland, CH
510(k) summary
Statement
Third party review
No

Clearances, product code ETW

Trailing 12 months

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

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