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510(k) K121228

PONTO BONE ANCHORED HEARING SYSTEM by Oticon Medical AB — Product Code MAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2012
Date Received
April 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Oticon Medical AB

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  • K203807 — Ponto Bone Anchored Hearing System, MONO Surgery Kit (March 3, 2021)
  • K190540 — Ponto 4 (May 2, 2019)
  • K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (September 29, 2016)
  • K152820 — Ponto Bone Anchored Hearing System (January 22, 2016)
  • K152067 — Ponto bone anchored hearing system (November 23, 2015)
  • K142678 — Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing (January 21, 2015)
  • K141616 — STERILIZATION CASSETTE (September 23, 2014)

Other clearances for product code MAH

  • K203807 — Ponto Bone Anchored Hearing System, MONO Surgery Kit (March 3, 2021)
  • K182116 — BA310 Abutment, BIA310 Implant/Abutment (December 19, 2018)
  • K152820 — Ponto Bone Anchored Hearing System (January 22, 2016)
  • K152067 — Ponto bone anchored hearing system (November 23, 2015)
  • K150555 — BA400 14mm Abutment (July 15, 2015)
  • K142678 — Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing (January 21, 2015)
  • K121317 — COCHLEAR BAHA IMPLANT SYSTEM (October 12, 2012)
  • K112053 — OBC BONE ANCHORED HEARING SYSTEM (November 18, 2011)
  • K080363 — BAHA CORDELLE II (April 10, 2008)
  • K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)