510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950888Substantially Equivalent

Screening Audiometry Word Recognition Audiometry

Calmed Technology, Inc., Union City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950888 is the FDA 510(k) clearance record for SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY, a class II device, cleared for Calmed Technology, Inc. on under FDA product code EWO (Audiometer). FDA records list 3 510(k) clearances for Calmed Technology, Inc., from to . As of , FDA records show no recalls naming K950888.

Clearance record

Decision date
Received
(21 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Calmed Technology, Inc. 29411 Kohoutek Way, Union City CA
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