Intrastar Pre-Wired Faceplate for In-The-Ear Hearing Aids

FDA 510(k) K961593 · Segi Hearing Aid Co.

Substantially Equivalent

510(k) numberK961593

Submission

Device name
Intrastar Pre-Wired Faceplate for In-The-Ear Hearing Aids
Applicant
Segi Hearing Aid Co.
New York, NY, US
Received
April 24, 1996
Decision date
November 7, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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)DeviceApplicantDecision
K974219Faceplate AssemblyLRB · Traditional Finetone Hearing Instruments02/20/1998SE
K942722Module ProgramLRB · Traditional Electone, Inc.09/06/1994SE
K942236Audina Prewires (Faceplate Hearing Aid Series)LRB · Traditional Audina Hearing Instrument06/17/1994SE
K935048Artisan Programmer & Hearing AidLRB · Traditional Telex Communications, Inc.02/09/1994SE
K933046Silver L Module, IteLRB · Traditional Electone, Inc.08/02/1993SE
K933045Silver Rechargeable Module, IteLRB · Traditional Electone, Inc.08/02/1993SE
K933044Silver LD Module, IteLRB · Traditional Electone, Inc.08/02/1993SE
K933043Silver PPP Module, IteLRB · Traditional Electone, Inc.08/02/1993SE
K933040Gold CD Module, IteLRB · Traditional Electone, Inc.08/02/1993SE
K933039Gold L Module, IteLRB · Traditional Electone, Inc.08/02/1993SE

Questions and answers

When was Intrastar Pre-Wired Faceplate for In-The-Ear Hearing Aids cleared by the FDA?

Intrastar Pre-Wired Faceplate for In-The-Ear Hearing Aids (K961593) received a 510(k) decision of Substantially Equivalent on November 7, 1996, 197 days after the submission was received.

What is the product code of K961593?

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