FDA 510(k)

C.CAM

K-Number: K031825 · 2003-06-20

ApplicantDanish Diagnostic Development A/S

Decision Date2003-06-20

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

C.CAM is the device name listed in this FDA 510(k) record. The listed applicant is Danish Diagnostic Development A/S. It received FDA 510(k) clearance on 2003-06-20 under 510(k) number K031825. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C.CAM?

C.CAM is a medical device that received FDA 510(k) clearance on 2003-06-20. The listed applicant is Danish Diagnostic Development A/S. The 510(k) number is K031825.

When did C.CAM receive FDA 510(k) clearance?

C.CAM received FDA 510(k) clearance on 2003-06-20, under 510(k) number K031825.

Who is the listed applicant for C.CAM?

The FDA 510(k) record lists Danish Diagnostic Development A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.CAM?

The FDA product code for C.CAM is KPS.

Other records listing Danish Diagnostic Development A/S as applicant

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.

K081829CAPIMAGE K051460C.CAM-AC K040616CARDIOMD-AC K011611CARDIOCAM MODEL 9CSY0799 K001888UNICORN MODEL SYS0630

Related Devices (Code: KPS)

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.