Earette Hearing Aid Sears #8054

FDA 510(k) K810379 · Oticon Corp.

Substantially Equivalent

510(k) numberK810379

Submission

Device name
Earette Hearing Aid Sears #8054
Applicant
Oticon Corp.
Mchenry, IL, US
Received
February 13, 1981
Decision date
March 4, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FSD – Binder, Abdominal
Device class
Class I (low risk)
Regulation
21 CFR 880.5160
Specialty
General Hospital

Other 510(k)s with product code FSD

510(k)DeviceApplicantDecision
K892379The Pouch Groin & Abdominal Stress AidFSD · Traditional Kuhn Industries07/20/1989SE
K822817Doce All-In-The-Ear AidFSD · Traditional Fidelty Hearing Instruments, Inc.01/18/1983SE
K770162Maternity SupporterFSD · Traditional R.G. Moore02/09/1977SE
K760772Disposable Abdominal BinderFSD · Traditional Tecnol New Jersey Wound Care, Inc.11/03/1976SE

More from Tecnol New Jersey Wound Care, Inc.

510(k)DeviceDecision
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K973885Oticon Digisound IteESD · Traditional 11/04/1997SE
K964683Digifocus IteESD · Traditional 12/12/1996SE
K963788Primofocus CompactESD · Traditional 11/27/1996SE
K961059Digifocus CompactESD · Traditional 05/07/1996SE
K960284Oticon /Primofocus (PF)ESD · Traditional 03/07/1996SE
K954794OticonESD · Traditional 11/13/1995SE
K950381Oticon/LogicESD · Traditional 02/27/1995SE
K946045OticonESD · Traditional 01/30/1995SE
K933307Multifocus Compact Bte Hearing AidESD · Traditional 08/23/1993SE

Questions and answers

When was Earette Hearing Aid Sears #8054 cleared by the FDA?

Earette Hearing Aid Sears #8054 (K810379) received a 510(k) decision of Substantially Equivalent on March 4, 1981, 19 days after the submission was received.

What is the product code of K810379?

The FDA product code is FSD – Binder, Abdominal, a Class I (low risk) device regulated under 21 CFR 880.5160.