Rionet Hearing Aid

FDA 510(k) K821508 · Rion Acoustic Instruments, Inc.

Substantially Equivalent

510(k) numberK821508

Submission

Device name
Rionet Hearing Aid
Applicant
Rion Acoustic Instruments, Inc.
Mchenry, IL, US
Received
May 21, 1982
Decision date
June 9, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

More from Rion Acoustic Instruments, Inc.

510(k)DeviceDecision
K874510Rionet Hearing Aid HB-75ESD · Traditional 02/23/1988SE
K862670Rionet Hearing Aid HB-35PTESD · Traditional 07/31/1986SE
K861728Rionet Hearing AidESD · Traditional 05/27/1986SE
K853638Rionet Hearing AidESD · Traditional 09/23/1985SE
K853637Rionet Hearing Aid HI-07ESD · Traditional 09/23/1985SE
K853636Rionet Hearing Aid HI-06ESD · Traditional 09/23/1985SE
K852453Rionet Hearing Aid HB-69HTESD · Traditional 08/22/1985SE
K852452Rionet Hearing Aid HB-71PESD · Traditional 08/21/1985SE
K852451Rionet Hearing Aid HB-34HTESD · Traditional 08/21/1985SE
K844059Rionet Hearing Aid HB-34ASESD · Traditional 12/03/1984SE

Questions and answers

When was Rionet Hearing Aid cleared by the FDA?

Rionet Hearing Aid (K821508) received a 510(k) decision of Substantially Equivalent on June 9, 1982, 19 days after the submission was received.