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510(k) K123962

OTOMAG BONE CONDUCTION HEARING SYSTEM by Sophono, Inc. — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2013
Date Received
December 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Bone Conduction
Device Class
Class II
Regulation Number
874.3302
Review Panel
EN
Submission Type

Other clearances by Sophono, Inc.

  • K153391 — Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (June 16, 2016)
  • K132189 — OTOMAG BONE CONDUCATION HEARING SYSTEM (November 22, 2013)
  • K102199 — OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) (May 23, 2011)
  • K100193 — OTOMAG BONE CONDUCTION HEARING SYSTEM (May 18, 2010)

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