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FDA 510(k)

DXL CALSCAN

K-Number: K033550 · 2004-05-05

ApplicantDemetech AB
Decision Date2004-05-05
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DXL CALSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Demetech AB. It received FDA 510(k) clearance on 2004-05-05 under 510(k) number K033550. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DXL CALSCAN?

DXL CALSCAN is a medical device that received FDA 510(k) clearance on 2004-05-05. The listed applicant is Demetech AB. The 510(k) number is K033550.

When did DXL CALSCAN receive FDA 510(k) clearance?

DXL CALSCAN received FDA 510(k) clearance on 2004-05-05, under 510(k) number K033550.

Who is the listed applicant for DXL CALSCAN?

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

What is the FDA product code for DXL CALSCAN?

The FDA product code for DXL CALSCAN is KGI.

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Related Devices (Code: KGI)

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

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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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