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FDA 510(k)

PONTO PRO

K-Number: K090996 · 2009-07-29

ApplicantOticon Medical AB
Decision Date2009-07-29
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PONTO PRO 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 2009-07-29 under 510(k) number K090996. 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 PRO?

PONTO PRO is a medical device that received FDA 510(k) clearance on 2009-07-29. The listed applicant is Oticon Medical AB. The 510(k) number is K090996.

When did PONTO PRO receive FDA 510(k) clearance?

PONTO PRO received FDA 510(k) clearance on 2009-07-29, under 510(k) number K090996.

Who is the listed applicant for PONTO PRO?

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 PRO?

The FDA product code for PONTO PRO is LXB.

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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.

K261142Ponto 5 Mini; Ponto 5 SuperpowerK240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSK213733Ponto 5 SuperPowerK211640Ponto 5 MiniK203807Ponto Bone Anchored Hearing System, MONO Surgery KitK190540Ponto 4

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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.

K253431Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)Shokz Health Global LimitedK254296Ossiclear (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 Mbh

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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