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510(k) K211640

Ponto 5 Mini by Oticon Medical AB — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2021
Date Received
May 27, 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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  • 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)

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  • 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)
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