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FDA 510(k)

ANEFIN, MODEL 100

K-Number: K033028 · 2005-07-22

ApplicantAxon Medical
Decision Date2005-07-22
Product CodeCBN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANEFIN, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Axon Medical. It received FDA 510(k) clearance on 2005-07-22 under 510(k) number K033028. The device is classified under product code CBN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANEFIN, MODEL 100?

ANEFIN, MODEL 100 is a medical device that received FDA 510(k) clearance on 2005-07-22. The listed applicant is Axon Medical. The 510(k) number is K033028.

When did ANEFIN, MODEL 100 receive FDA 510(k) clearance?

ANEFIN, MODEL 100 received FDA 510(k) clearance on 2005-07-22, under 510(k) number K033028.

Who is the listed applicant for ANEFIN, MODEL 100?

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

What is the FDA product code for ANEFIN, MODEL 100?

The FDA product code for ANEFIN, MODEL 100 is CBN.

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Related Devices (Code: CBN)

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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