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
K964080Substantially Equivalent

Lori Hearing Aid Simulator

Lori Medical Laboratories, Inc., Golden Valley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964080 is the FDA 510(k) clearance record for LORI HEARING AID SIMULATOR, a class II device, cleared for Lori Medical Laboratories, Inc. on under FDA product code KHL (Hearing Aid, Master). FDA records list 8 510(k) clearances for Lori Medical Laboratories, Inc., from to . As of , FDA records show no recalls naming K964080.

Clearance record

Decision date
Received
(89 days to decision)
Product code
KHL Hearing Aid, Master
Regulation
21 CFR 874.3330
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Lori Medical Laboratories, Inc. 696 Mendelssohn Ave. N., Golden Valley MN
510(k) summary
Statement
Third party review
No

Clearances, product code KHL

Trailing 12 months

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

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