EARETTE HEARING AID SEARS #8054— 510(k) K810379

Substantially Equivalent

Oticon Corp.

FDA 510(k) clearance K810379 for EARETTE HEARING AID SEARS #8054, Substantially Equivalent on 1981-03-04. Applicant: Oticon Corp.. Device class: 1.

Clearance details

Applicant: Oticon Corp.
Product code: Code FSD
Device class: Class 1
Regulation: 21 CFR 880.5160
Advisory panel: General Hospital
Date received: 1981-02-13
Decision date: 1981-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSD

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K822817 — DOCE ALL-IN-THE-EAR AID1983-01-18
K770162 — MATERNITY SUPPORTER1977-02-09
K760772 — DISPOSABLE ABDOMINAL BINDER1976-11-03

More clearances from Oticon Corp.

K963788 — PRIMOFOCUS COMPACT1996-11-27
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K923490 — BTE HEARING AID PERSONIC 4101992-08-06
K923491 — BTE HEARING AID PERSONIC 4251992-08-06

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