K821508Substantially Equivalent

Rionet Hearing Aid

Name: K821508 Rionet Hearing Aid
Creator: Rion Acoustic Instruments, Inc.
Published: 1982-06-09
License: https://open.fda.gov/license/

Rion Acoustic Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K821508 is the FDA 510(k) clearance record for RIONET HEARING AID, cleared for Rion Acoustic Instruments, Inc. on 1982-06-09. FDA records list 51 510(k) clearances for Rion Acoustic Instruments, Inc., from 1979-10-26 to 1988-02-23. As of 2026-09-10, FDA records show no recalls naming K821508.

Clearance record

Decision date: 1982-06-09
Received: 1982-05-21 (19 days to decision)
Review panel: Unknown
Applicant: Rion Acoustic Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No