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510(k) K802812

RIONET HEARING AID by Kindel & Anderson — Product Code KHL

K802812 is an FDA 510(k) premarket notification submitted by Kindel & Anderson for the device "RIONET HEARING AID". The FDA issued a decision of Substantially Equivalent on November 26, 1980. The device falls under product code KHL (Hearing Aid, Master), a Class II device regulated under 21 CFR 874.3330. Kindel & Anderson has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1980
Date Received
November 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Master
Device Class
Class II
Regulation Number
874.3330
Review Panel
EN
Submission Type

Other clearances by Kindel & Anderson

  • K823384 — HEARING AID HB-72 RIONET (December 9, 1982)
  • K823383 — HEARING AID HB-33 RIONET (December 9, 1982)
  • K802870 — RION ELECTRO-PALATOGRAPH MODEL DP-01 (December 17, 1980)

Other clearances for product code KHL

  • K964080 — LORI HEARING AID SIMULATOR (January 8, 1997)
  • K911726 — PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION (October 23, 1991)
  • K894019 — RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE (September 21, 1989)
  • K860171 — VOROBA PROGRAMMABLE AUDITORY COMPARATOR (May 2, 1986)
  • K854126 — CRAIGWELL MASTER HEARING AID MHA (January 16, 1986)
  • K790481 — MODEL FS1 (April 3, 1979)

FDA data resources