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FDA 510(k)

CADIMAS VERSION 1.0

K-Number: K052023 · 2005-12-08

ApplicantAlan Penn & Associates., Inc.
Decision Date2005-12-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CADIMAS VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Alan Penn & Associates., Inc.. It received FDA 510(k) clearance on 2005-12-08 under 510(k) number K052023. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADIMAS VERSION 1.0?

CADIMAS VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2005-12-08. The listed applicant is Alan Penn & Associates., Inc.. The 510(k) number is K052023.

When did CADIMAS VERSION 1.0 receive FDA 510(k) clearance?

CADIMAS VERSION 1.0 received FDA 510(k) clearance on 2005-12-08, under 510(k) number K052023.

Who is the listed applicant for CADIMAS VERSION 1.0?

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

What is the FDA product code for CADIMAS VERSION 1.0?

The FDA product code for CADIMAS VERSION 1.0 is LNH.

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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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