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FDA 510(k)

twion

K-Number: K151717 · 2016-02-23

ApplicantAlber GmbH
Decision Date2016-02-23
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

twion is the device name listed in this FDA 510(k) record. The listed applicant is Alber GmbH. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K151717. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the twion?

twion is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Alber GmbH. The 510(k) number is K151717.

When did twion receive FDA 510(k) clearance?

twion received FDA 510(k) clearance on 2016-02-23, under 510(k) number K151717.

Who is the listed applicant for twion?

The FDA 510(k) record lists Alber GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for twion?

The FDA product code for twion is ITI.

Other records listing Alber GmbH 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.

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Related Devices (Code: ITI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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