510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K802963Substantially Equivalent

101, 151, 161 Portable Audiometers

Amplaid USA, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802963 is the FDA 510(k) clearance record for 101, 151, 161 PORTABLE AUDIOMETERS, a class II device, cleared for Amplaid USA, Inc. on under FDA product code EWO (Audiometer). FDA records list 8 510(k) clearances for Amplaid USA, Inc., from to . As of , FDA records show no recalls naming K802963.

Clearance record

Decision date
Received
(28 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Amplaid USA, Inc. 803 N. Front St. Suite 3, Mchenry IL
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