Cleared Traditional

K790481 - MODEL FS1 (FDA 510(k) Clearance)

K790481 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Apr 1979
Decision
26d
Days
Class 2
Risk

K790481 is an FDA 510(k) clearance for the MODEL FS1. This device is classified as a Hearing Aid, Master (Class II - Special Controls, product code KHL).

Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979, 26 days after receiving the submission on March 8, 1979.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3330.

Submission Details

510(k) Number K790481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1979
Decision Date April 03, 1979
Days to Decision 26 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -

Device Classification

Product Code KHL - Hearing Aid, Master
Device Class Class II - Special Controls
CFR Regulation 21 CFR 874.3330