Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
K-Number: K161671 · 2016-09-29
Device Summary
Frequently Asked Questions
What is the Ponto 3, Ponto 3 Power and Ponto 3 SuperPower?
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Oticon Medical AB. The 510(k) number is K161671.
When did Ponto 3, Ponto 3 Power and Ponto 3 SuperPower receive FDA 510(k) clearance?
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower received FDA 510(k) clearance on 2016-09-29, under 510(k) number K161671.
Who is the listed applicant for Ponto 3, Ponto 3 Power and Ponto 3 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 3, Ponto 3 Power and Ponto 3 SuperPower?
The FDA product code for Ponto 3, Ponto 3 Power and Ponto 3 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.
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.