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FDA 510(k)

Ponto 5 Mini

K-Number: K211640 · 2021-08-10

ApplicantOticon Medical AB
Decision Date2021-08-10
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ponto 5 Mini is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Medical AB. It received FDA 510(k) clearance on 2021-08-10 under 510(k) number K211640. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ponto 5 Mini?

Ponto 5 Mini is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is Oticon Medical AB. The 510(k) number is K211640.

When did Ponto 5 Mini receive FDA 510(k) clearance?

Ponto 5 Mini received FDA 510(k) clearance on 2021-08-10, under 510(k) number K211640.

Who is the listed applicant for Ponto 5 Mini?

The FDA 510(k) record lists Oticon Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ponto 5 Mini?

The FDA product code for Ponto 5 Mini is LXB.

Other records listing Oticon Medical AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSK213733Ponto 5 SuperPowerK203807Ponto Bone Anchored Hearing System, MONO Surgery KitK190540Ponto 4K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerK152820Ponto Bone Anchored Hearing System

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Related Devices (Code: LXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254296Ossiclear (Ossiclear System)SounductK260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)Zdeer Technology (Henan) Co., Ltd.K261256Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd.K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandCochlearK243041contact forte AlphaBhm-Tech Produktionsgesellschaft MbhK213733Ponto 5 SuperPowerOticon Medical AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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