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510(k) K860171

VOROBA PROGRAMMABLE AUDITORY COMPARATOR by Voroba Technologies Assoc. — Product Code KHL

K860171 is an FDA 510(k) premarket notification submitted by Voroba Technologies Assoc. for the device "VOROBA PROGRAMMABLE AUDITORY COMPARATOR". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code KHL (Hearing Aid, Master), a Class II device regulated under 21 CFR 874.3330. Voroba Technologies Assoc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
January 17, 1986
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 Voroba Technologies Assoc.

  • K860170 — VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID (April 17, 1986)

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)
  • K854126 — CRAIGWELL MASTER HEARING AID MHA (January 16, 1986)
  • K802812 — RIONET HEARING AID (November 26, 1980)
  • K790481 — MODEL FS1 (April 3, 1979)

FDA data resources