In the Ear & in the Canal Hearing Aid Face Plate

Q: What is the product code of K871884?

The FDA product code is LRB – Face Plate Hearing Aid, a Class I (low risk) device regulated under 21 CFR 874.3300.

FDA 510(k) K871884 · Hearing Services, Inc.

Substantially Equivalent

510(k) numberK871884

Submission

Device name: In the Ear & in the Canal Hearing Aid Face Plate
Applicant: Hearing Services, Inc.
Eden Prairie, MN, US
Received: May 13, 1987
Decision date: October 27, 1987
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LRB – Face Plate Hearing Aid
Device class: Class I (low risk)
Regulation: 21 CFR 874.3300
Specialty: Ear, Nose, Throat

Other 510(k)s with product code LRB

510(k)	Device	Applicant	Decision
K974219	Faceplate AssemblyLRB · Traditional	Finetone Hearing Instruments	02/20/1998SE
K961593	Intrastar Pre-Wired Faceplate for In-The-Ear Hearing AidsLRB · Traditional	Segi Hearing Aid Co.	11/07/1996SE
K942722	Module ProgramLRB · Traditional	Electone, Inc.	09/06/1994SE
K942236	Audina Prewires (Faceplate Hearing Aid Series)LRB · Traditional	Audina Hearing Instrument	06/17/1994SE
K935048	Artisan Programmer & Hearing AidLRB · Traditional	Telex Communications, Inc.	02/09/1994SE
K933046	Silver L Module, IteLRB · Traditional	Electone, Inc.	08/02/1993SE
K933045	Silver Rechargeable Module, IteLRB · Traditional	Electone, Inc.	08/02/1993SE
K933044	Silver LD Module, IteLRB · Traditional	Electone, Inc.	08/02/1993SE
K933043	Silver PPP Module, IteLRB · Traditional	Electone, Inc.	08/02/1993SE
K933040	Gold CD Module, IteLRB · Traditional	Electone, Inc.	08/02/1993SE

More from Electone, Inc.

510(k)	Device	Decision
K832701	Hsi Elite #Ec Custom Canal Hear-AidESD · Traditional	09/29/1983SE
K790737	Hsi Model C. Custom In-The-Ear Hear/AidESD · Traditional	05/16/1979SE

Questions and answers

When was In the Ear & in the Canal Hearing Aid Face Plate cleared by the FDA?

In the Ear & in the Canal Hearing Aid Face Plate (K871884) received a 510(k) decision of Substantially Equivalent on October 27, 1987, 167 days after the submission was received.

What is the product code of K871884?

The FDA product code is LRB – Face Plate Hearing Aid, a Class I (low risk) device regulated under 21 CFR 874.3300.