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FDA 510(k)

Ponto 5 SuperPower

K-Number: K213733 · 2021-12-16

Decision Date2021-12-16
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ponto 5 SuperPower 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 2021-12-16 under 510(k) number K213733. 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 SuperPower?

Ponto 5 SuperPower is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Oticon Medical AB. The 510(k) number is K213733.

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

Ponto 5 SuperPower received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213733.

Who is the listed applicant for Ponto 5 SuperPower?

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 SuperPower?

The FDA product code for Ponto 5 SuperPower 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.

View all 7 devices →

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.

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.