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510(k) K213733

Ponto 5 SuperPower by Oticon Medical AB — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2021
Date Received
November 26, 2021
Clearance Type
Special
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 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)
  • K132775 — PONTO PLUS AND PONTO PLUS POWER (December 9, 2013)

Other clearances for product code LXB

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  • K211640 — Ponto 5 Mini (August 10, 2021)
  • K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear (February 23, 2021)
  • K190540 — Ponto 4 (May 2, 2019)
  • K172460 — ADHEAR System (April 27, 2018)
  • K171088 — Cochlear Baha SoundArc (June 7, 2017)
  • K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (September 29, 2016)
  • K153391 — Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (June 16, 2016)