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FDA 510(k)

ACCUFRAME

K-Number: K081157 · 2008-07-22

ApplicantCagenix, Inc.
Decision Date2008-07-22
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCUFRAME is the device name listed in this FDA 510(k) record. The listed applicant is Cagenix, Inc.. It received FDA 510(k) clearance on 2008-07-22 under 510(k) number K081157. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUFRAME?

ACCUFRAME is a medical device that received FDA 510(k) clearance on 2008-07-22. The listed applicant is Cagenix, Inc.. The 510(k) number is K081157.

When did ACCUFRAME receive FDA 510(k) clearance?

ACCUFRAME received FDA 510(k) clearance on 2008-07-22, under 510(k) number K081157.

Who is the listed applicant for ACCUFRAME?

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

What is the FDA product code for ACCUFRAME?

The FDA product code for ACCUFRAME is NHA.

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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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