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FDA 510(k)

PONTO PRO POWER

K-Number: K103594 · 2011-06-15

ApplicantOticon Medical AB
Decision Date2011-06-15
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PONTO PRO 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 2011-06-15 under 510(k) number K103594. 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 POWER?

PONTO PRO POWER is a medical device that received FDA 510(k) clearance on 2011-06-15. The listed applicant is Oticon Medical AB. The 510(k) number is K103594.

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

PONTO PRO POWER received FDA 510(k) clearance on 2011-06-15, under 510(k) number K103594.

Who is the listed applicant for PONTO PRO 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 PRO POWER?

The FDA product code for PONTO PRO POWER is LXB.

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Other records listing Oticon Medical AB as applicant

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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.

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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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