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510(k) K854126

CRAIGWELL MASTER HEARING AID MHA by Craigwell Electronics, Ltd. — Product Code KHL

K854126 is an FDA 510(k) premarket notification submitted by Craigwell Electronics, Ltd. for the device "CRAIGWELL MASTER HEARING AID MHA". The FDA issued a decision of Substantially Equivalent on January 16, 1986. The device falls under product code KHL (Hearing Aid, Master), a Class II device regulated under 21 CFR 874.3330. Craigwell Electronics, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1986
Date Received
October 9, 1985
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 Craigwell Electronics, Ltd.

  • K854124 — CRAIGWELL AID HA300 (March 26, 1986)
  • K854125 — CRAIGWELL AID FITTING SYSTEM AFS (January 16, 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)
  • K860171 — VOROBA PROGRAMMABLE AUDITORY COMPARATOR (May 2, 1986)
  • K802812 — RIONET HEARING AID (November 26, 1980)
  • K790481 — MODEL FS1 (April 3, 1979)

FDA data resources