Rionet Hearing Aid

FDA 510(k) K802812 · Kindel & Anderson

Substantially Equivalent

510(k) numberK802812

Submission

Device name
Rionet Hearing Aid
Applicant
Kindel & Anderson
Walker, MI, US
Received
November 7, 1980
Decision date
November 26, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KHL – Hearing Aid, Master
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3330
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KHL

510(k)DeviceApplicantDecision
K964080Lori Hearing Aid SimulatorKHL · Traditional Lori Medical Laboratories, Inc.01/08/1997SE
K911726Programmable Auditory Comparator, ModificationKHL · Traditional Bausch & Lomb, Inc.10/23/1991SE
K894019Resound Demo. Behind-The-Ear Hrng., Model Demo BteKHL · Traditional Resound Corp.09/21/1989SE
K860171Voroba Programmable Auditory ComparatorKHL · Traditional Voroba Technologies Assoc.05/02/1986SE
K854126Craigwell Master Hearing Aid MhaKHL · Traditional Craigwell Electronics, Ltd.01/16/1986SE
K790481Model FS1KHL · Traditional Starkey Laboratories, Inc.04/03/1979SE

More from Starkey Laboratories, Inc.

510(k)DeviceDecision
K823384Hearing Aid HB-72 RionetESD · Traditional 12/09/1982SE
K823383Hearing Aid HB-33 RionetESD · Traditional 12/09/1982SE
K802870Rion Electro-Palatograph Model DP-01LEZ · Traditional 12/17/1980SE

Questions and answers

When was Rionet Hearing Aid cleared by the FDA?

Rionet Hearing Aid (K802812) received a 510(k) decision of Substantially Equivalent on November 26, 1980, 19 days after the submission was received.

What is the product code of K802812?

The FDA product code is KHL – Hearing Aid, Master, a Class II (moderate risk) device regulated under 21 CFR 874.3330.