SONOTONE BEHIND THE EAR MODEL ST 47I— 510(k) K914898

Name: FDA 510(k) clearance K914898
Creator: U.S. Food and Drug Administration
Published: 1992-01-09

Substantially Equivalent

Sonotone Hearing Instruments

FDA 510(k) clearance K914898 for SONOTONE BEHIND THE EAR MODEL ST 47I, Substantially Equivalent on 1992-01-09. Applicant: Sonotone Hearing Instruments. Device class: 1.

Clearance details

Applicant: Sonotone Hearing Instruments
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1991-10-31
Decision date: 1992-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longwood, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ESD

view all

K232999 — Lyric4 Hearing Aid2024-04-11
K130790 — LYRIC22013-06-27
K081136 — LYRIC HEARING AID2008-05-08
K021867 — INSOUND XT SERIES HEARING AID2002-11-19
K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)2001-04-24

More clearances from Sonotone Hearing Instruments

view all

K914899 — SONOTONE BEHIND THE EAR MODEL ST 45G1992-01-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.