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510(k) K964080

LORI HEARING AID SIMULATOR by Lori Medical Laboratories, Inc. — Product Code KHL

K964080 is an FDA 510(k) premarket notification submitted by Lori Medical Laboratories, Inc. for the device "LORI HEARING AID SIMULATOR". The FDA issued a decision of Substantially Equivalent on January 8, 1997. The device falls under product code KHL (Hearing Aid, Master), a Class II device regulated under 21 CFR 874.3330. Lori Medical Laboratories, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1997
Date Received
October 11, 1996
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 Lori Medical Laboratories, Inc.

  • K973376 — LORI/LORI, LORI-S (LORI STOCK AID) (October 14, 1997)
  • K972058 — LORIPRO, LORIPRO II (August 15, 1997)
  • K952711 — LORI-A (July 3, 1995)
  • K940639 — LORI-CIC HEARING AID (March 25, 1994)
  • K893721 — LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT (September 8, 1989)
  • K893722 — LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT (September 8, 1989)
  • K893723 — LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT (September 8, 1989)

Other clearances for product code KHL

  • 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)
  • K802812 — RIONET HEARING AID (November 26, 1980)
  • K790481 — MODEL FS1 (April 3, 1979)

FDA data resources