FDA 510(k)

ACRIFIX

K-Number: K230341 · 2023-04-06

Decision Date2023-04-06

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ACRIFIX is the device name listed in this FDA 510(k) record. The listed applicant is Deltamed GmbH. It received FDA 510(k) clearance on 2023-04-06 under 510(k) number K230341. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRIFIX?

ACRIFIX is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is Deltamed GmbH. The 510(k) number is K230341.

When did ACRIFIX receive FDA 510(k) clearance?

ACRIFIX received FDA 510(k) clearance on 2023-04-06, under 510(k) number K230341.

Who is the listed applicant for ACRIFIX?

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

What is the FDA product code for ACRIFIX?

The FDA product code for ACRIFIX is EBI.

Other records listing Deltamed GmbH as applicant

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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.