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FDA 510(k)

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

K-Number: K240614 · 2024-07-10

ApplicantOticon Medical AB
Decision Date2024-07-10
Product CodePFO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS 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 2024-07-10 under 510(k) number K240614. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS?

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS is a medical device that received FDA 510(k) clearance on 2024-07-10. The listed applicant is Oticon Medical AB. The 510(k) number is K240614.

When did Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS receive FDA 510(k) clearance?

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS received FDA 510(k) clearance on 2024-07-10, under 510(k) number K240614.

Who is the listed applicant for Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS?

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 Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS?

The FDA product code for Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS is PFO.

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Related Devices (Code: PFO)

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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