Cleared Traditional

FACEPLATE ASSEMBLY

K974219 · Finetone Hearing Instruments · Ear, Nose, Throat

Feb 1998

Decision

102d

Days

Class 1

Risk

About This 510(k) Submission

K974219 is an FDA 510(k) clearance for the FACEPLATE ASSEMBLY, a Face Plate Hearing Aid (Class I — General Controls, product code LRB), submitted by Finetone Hearing Instruments (Scarborough, US). The FDA issued a Cleared decision on February 20, 1998, 102 days after receiving the submission on November 10, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K974219 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 1997
Decision Date	February 20, 1998
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement