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FDA 510(k)

PONTO PLUS AND PONTO PLUS POWER

K-Number: K132775 · 2013-12-09

ApplicantOticon Medical AB
Decision Date2013-12-09
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PONTO PLUS AND PONTO PLUS POWER 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 2013-12-09 under 510(k) number K132775. 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 PLUS AND PONTO PLUS POWER?

PONTO PLUS AND PONTO PLUS POWER is a medical device that received FDA 510(k) clearance on 2013-12-09. The listed applicant is Oticon Medical AB. The 510(k) number is K132775.

When did PONTO PLUS AND PONTO PLUS POWER receive FDA 510(k) clearance?

PONTO PLUS AND PONTO PLUS POWER received FDA 510(k) clearance on 2013-12-09, under 510(k) number K132775.

Who is the listed applicant for PONTO PLUS AND PONTO PLUS POWER?

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 PLUS AND PONTO PLUS POWER?

The FDA product code for PONTO PLUS AND PONTO PLUS POWER is LXB.

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Other records listing Oticon Medical AB as applicant

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Related Devices (Code: LXB)

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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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