Cleared Special

Ponto 5 Mini

K211640 · Oticon Medical AB · Ear, Nose, Throat
Aug 2021
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K211640 is an FDA 510(k) clearance for the Ponto 5 Mini, a Hearing Aid, Bone Conduction (Class II — Special Controls, product code LXB), submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on August 10, 2021, 75 days after receiving the submission on May 27, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3302.

Submission Details

510(k) Number K211640 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2021
Decision Date August 10, 2021
Days to Decision 75 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LXB — Hearing Aid, Bone Conduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3302

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