Cleared Traditional

PRECISE IMPRESSION KIT

K970952 · Starkey Laboratories, Inc. · Ear, Nose, Throat

May 1997

Decision

49d

Days

Class 1

Risk

About This 510(k) Submission

K970952 is an FDA 510(k) clearance for the PRECISE IMPRESSION KIT, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 2, 1997, 49 days after receiving the submission on March 14, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K970952 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 1997
Decision Date	May 02, 1997
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — General Controls
CFR Regulation	21 CFR 874.3300
Definition	An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.