Cleared Traditional

VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229

K935701 · Starkey Laboratories, Inc. · Ear, Nose, Throat
May 1994
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K935701 is an FDA 510(k) clearance for the VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229, a Hearing Aid, Bone Conduction (Class II — Special Controls, product code LXB), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 10, 1994, 161 days after receiving the submission on November 30, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3302.

Submission Details

510(k) Number K935701 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1993
Decision Date May 10, 1994
Days to Decision 161 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LXB — Hearing Aid, Bone Conduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3302

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