Ponto 4
K-Number: K190540 · 2019-05-02
Device Summary
Frequently Asked Questions
What is the Ponto 4?
Ponto 4 is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Oticon Medical AB. The 510(k) number is K190540.
When did Ponto 4 receive FDA 510(k) clearance?
Ponto 4 received FDA 510(k) clearance on 2019-05-02, under 510(k) number K190540.
Who is the listed applicant for Ponto 4?
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 4?
The FDA product code for Ponto 4 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.
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.