LORI HEARING AID SIMULATOR— 510(k) K964080

Name: FDA 510(k) clearance K964080
Creator: U.S. Food and Drug Administration
Published: 1997-01-08

Substantially Equivalent

Lori Medical Laboratories, Inc.

FDA 510(k) clearance K964080 for LORI HEARING AID SIMULATOR, Substantially Equivalent on 1997-01-08. Applicant: Lori Medical Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Lori Medical Laboratories, Inc.
Product code: Code KHL
Device class: Class 2
Regulation: 21 CFR 874.3330
Advisory panel: Ear, Nose, Throat
Date received: 1996-10-11
Decision date: 1997-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden Valley, MN, US

Download summary PDF View on FDA.gov ↗

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